Lumbar Plexus vs Quadratus Lumborum Block in Post-operati... | NCT03801265

Lumbar Plexus vs Quadratus Lumborum Block in Post-operati... | NCT03801265 | Trialant

Description Module

Brief Summary

The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia technique to provide postoperative pain management after primary hip replacement surgery at UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with potentially serious side effects, including nerve injury, major bleeding, retroperitoneal hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can also lead to motor blockade, interfering with early ambulation. There are several case reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief after total hip replacement surgery, and this QL3 block is performed routinely at this institution. The benefits to inter-fascial administration of local anesthetic include the avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration associated with the direct interaction between the nerve and the nerve block needle. The purpose of this study is to show that QL3 block is non-inferior to the standard-of-care lumbar plexus block and should be used more regularly in hip replacement surgery. The study will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority, active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block for post-operative pain management in subjects undergoing primary, unilateral hip replacement surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and physical therapy response. Primary outcome measures include pain at rest and with movement at 6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by a physical therapist.

Detailed Description

Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative area on their day of surgery. The anesthesiology investigator will speak with the patient about the study behind a closed drape and the patient will have adequate time to consider the consent and ask questions regarding risk factors associated with each type of block. Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups. Once assigned the treatment allocation, only the clinician administering the block will be unblinded to the randomization outcome. If randomized to the LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. For both treatment groups, the local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary outcome measures. These include pain at rest and with movement at 6, 12 and 24 hours after surgery, time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by physical therapist. This information will be captured from the patient's electronic medical record.

Minor changes were made to the outcome measures after the original approval of this submission. This was only to clarify the specific measures from the more general descriptions in the original.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar Plexus block	Active Comparator	0.5% ropivacaine 100 mg (20 ml) will be injected	Procedure: Lumbar plexus block Drug: Ropivacaine injection
Quadratus Lumborum type 3 block	Experimental	0.5% ropivacaine 100 mg (20 ml) will be injected	Procedure: Quadratus lumborum type 3 block Drug: Ropivacaine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar plexus block	Procedure	Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain at Rest After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.	6 hours after surgery
Pain With Movement After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.	6 hours after surgery
Pain at Rest After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.	12 hours after surgery
Pain With Movement After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.	12 hours after surgery
Pain at Rest After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.	24 hours after surgery
Pain With Movement After Surgery	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.	24 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
Pain During Physical Therapy	Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.	24 hours after surgery
Total Opioid Consumption During 24 Hours After Surgery

Contacts/Locations Module

Name	Affiliation	Role
Sharad Khetarpal, MD	Department of Anesthesiology, University of Pittsburgh Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Presbyterian-Shadyside Hospital		Pittsburgh	Pennsylvania	15232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18719448	Background	Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
12552223

Arm/Group Information

ID	Title	Description
FG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
FG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00023 subjects FG00123 subjects
COMPLETED		FG00023 subjects FG00123 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Posted

Mean

Standard Deviation

score on a scale

6 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Sharad Khetarpal, MD	University of Pittsburgh	4126235020		khetarpalsk@upmc.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 5, 2019	May 27, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jun 5, 2019	May 27, 2021	SAP_001.pdf

Condition Browse Module

ID	Term
D015207	Osteoarthritis, Hip

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Intervention Browse Module

ID	Term
D000077212	Ropivacaine

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.770														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Posted

Mean

Standard Deviation

score on a scale

6 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0004.9± 3.2 OG0014.7± 2.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.826														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Posted

Mean

Standard Deviation

score on a scale

12 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0003.0± 2.9 OG0012.8± 2.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.859														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Posted

Mean

Standard Deviation

score on a scale

12 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0004.5± 2.8 OG0014.6± 2.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.904														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Primary

Pain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Posted

Median

Standard Deviation

score on a scale

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0002.8± 2.6 OG0011.8± 1.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.122														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Primary

Pain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Posted

Median

Standard Deviation

score on a scale

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0004.9± 2.8 OG0014.3± 1.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.379														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Pain During Physical Therapy

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Posted

Mean

Standard Deviation

score on a scale

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0004.3± 2.5 OG0014.2± 1.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.881														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Opioid Consumption During 24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Posted

Mean

Standard Deviation

mg oral morphine equivalents

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG00014.0± 9.3 OG00114.7± 10.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.818														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Postoperative Time to Accomplish Walking 100 Feet

This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.

Posted

Mean

Standard Deviation

minutes

within 24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0001449.1± 760.7 OG0011358.3± 715.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.678														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Block Procedure Duration

Duration that the patient underwent the block procedure during surgery in minutes

Posted

Mean

Standard Deviation

minutes

during surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG00011.7± 6.1 OG0016.6± 4.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.002														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Patients With Postoperative Quadriceps Weakness

patients who report having post-surgical quadriceps weakness.

Posted

Count of Participants

Participants

12 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG00015 OG0016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		.007														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Acetaminophen Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)

Posted

Mean

Standard Deviation

milligrams (mg)

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0002782.6± 902.3 OG0013087.0± 949.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.271														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Celecoxib Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)

Posted

Mean

Standard Deviation

milligrams (mg)

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG000191.3± 185.7 OG001178.3± 180.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.810														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Ketorolac Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)

Posted

Mean

Standard Deviation

milligrams (mg)

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0009.8± 17.3 OG00112.4± 24.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.676														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Gabapentin Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)

Posted

Mean

Standard Deviation

milligrams (mg)

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG000382.6± 238.7 OG001395.7± 481.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.908														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Total Oral Ketamine Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)

Posted

Mean

Standard Deviation

milligrams (mg)

24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0007.4± 12.5 OG00113.5± 22.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.270														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Opioid Consumption During 0-6 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Posted

Mean

Standard Deviation

mg oral morphine equivalents

6 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0003.4± 3.2 OG0016.3± 4.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.015														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Opioid Consumption During 6-12 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Posted

Mean

Standard Deviation

mg oral morphine equivalents

6-12 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0005.0± 4.2 OG0013.4± 4.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.203														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).

Secondary

Opioid Consumption During 12-24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Posted

Mean

Standard Deviation

mg oral morphine equivalents

12-24 hours after surgery

ID	Title	Description
OG000	Lumbar Plexus Block	0.5% ropivacaine 100 mg (20 ml) will be injected Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
OG001	Quadratus Lumborum Type 3 Block	0.5% ropivacaine 100 mg (20 ml) will be injected Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0005.7± 4.6 OG0015.0± 5.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		.672														Non-Inferiority	The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).