Four Quadrants Transverse Abdominus Plane (4Q-TAP) Block... | NCT03359811

NCT03359811

ID	Type	Description	Link
NCI-2018-00999	Other Identifier	NCI

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

Baseline Tests:

If participant agrees to take part in this study, within 60 days before participant's surgery:

Participant will have a physical exam.
Blood (about 8 teaspoons) will be drawn for routine tests.
Participant will complete a questionnaire about the quality of recovery. Participant's responses before surgery will be compared to participant's responses after surgery. It should take about 5 minutes to complete.

Study Groups/Procedures:

Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups on the morning of participant's surgery. This is done because no one knows if one study group is better, the same, or worse than the other group.

If participant is in Group 1, participant will receive standard-of-care TEA before participant goes to sleep.
If participant is in Group 2, participant will receive the 4Q-TAP block injections after participant is asleep.

If participant is in Group 1, participant will have a catheter placed in participant's back before surgery so that the TEA can be infused. If needed, participant may receive an injection of numbing medication and/or pain medication before the catheter is placed. Participant will sign a separate consent for the placement of the catheter.

If participant is in Group 2, participant will receive up to four (4) injections of 4Q-TAP block directly into different parts of the abdomen. These injections will take place after participant has been given general anesthesia. An ultrasound will be used to guide these injections. Participant will not be awake for these injections.

Both groups will sign a separate consent for the surgery that explains the procedures and the risks. Participant may receive standard drugs during surgery. The study staff can tell participant about the risks of these drugs and how they are given.

For both groups, information about the surgery will be collected while participant is in the operating room.

Post-Surgery:

After surgery, participant will receive standard drugs for pain as needed. Participant will be asked to complete a questionnaire about the quality of participant's recovery on the following days after surgery:

Days 1-3
Day 5
Day 7
Day 10 and
Day 30

The questionnaire should take about 5 minutes each time. Participant will complete the questionnaire in person or participant will be called on the phone to complete it if participant has already left the hospital.

On Days 1, 2, and 7 after surgery, blood (about 8 teaspoons each time) will be drawn for routine tests.

After participant leaves the hospital, researchers will collect information from participant's medical record about participant's standard follow-up visits.

Length of Study Participation:

Active participation in this study will be complete 30 days after the surgery.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard-of-Care Thoracic Epidural Analgesia (TEA)	Experimental	An epidural catheter placed before induction of anesthesia by an anesthesiologist. A bolus or infusion of the local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.	Drug: Local Anesthetic Solution
4Q-TAP Blocks	Active Comparator	Participants have an ultrasound guided 4Q-TAP block. A maximum of 80 cc of a solution consisting of 30 mg of bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) and 65 mg of liposomal bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.	Drug: Bupivacaine HCl Drug: Liposomal Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local Anesthetic Solution	Drug	A bolus or infusion of local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of TEA vs 4Q-TAP in QoR at Postoperative Day (POD)2	To compare the efficacy of 4 quadrants TAP blocks (4Q-TAP) versus Thoracic Epidural Analgesia (routine care) on the quality of recovery 48 hours after CRS-HIPEC surgery, measure by QoR-15 changes from Pre-Op to POD2. The QoR scale is a validated scoring system that allows for the quantification of a patient's early postoperative health status. The minimum score 0 and maximum score 150. The higher score mean a better outcome.	48 hours after CRS-HIPEC surgery

Secondary Outcomes

Measure	Description	Time Frame
4Q-TAP Versus TEA on Postoperative Pain	Pain intensity at rest and cough measure using a Validity and Reliability of the Verbal Numerical Rating Scale (VNRS) (0 = no pain - 10 = worst pain ever). Higher numerical scores on the scale indicate more pain, thus a worse outcome. Data reported as time-weighted pain scores from discharge from the PACU until 48 hours after the end of surgery.	48 hours after CRS-HIPEC surgery

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Juan P. Cata, MD	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Label	URL
University of Texas MD Anderson Cancer Center Website	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 12, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Standard-of-Care Thoracic Epidural Analgesia (TEA)

Baseline demographics data is only available for the participants who completed the study

Arm/Group Information

ID	Title	Description
BG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
BG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00033 BG00135 BG00268

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG000-45(-89 to 0) OG001-50(-88 to 23)

Secondary

4Q-TAP Versus TEA on Postoperative Pain

Pain intensity at rest and cough measure using a Validity and Reliability of the Verbal Numerical Rating Scale (VNRS) (0 = no pain - 10 = worst pain ever). Higher numerical scores on the scale indicate more pain, thus a worse outcome. Data reported as time-weighted pain scores from discharge from the PACU until 48 hours after the end of surgery.

Posted

Median

Full Range

score on a scale

48 hours after CRS-HIPEC surgery

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Secondary

Comparison of the Total Opioid Consumption Between Patients With 4Q-TAP Versus TEA

Opioid Consumption reported as morphine equivalents required during the 48 hours after the end of surgery.

Posted

Median

Full Range

morphine milligram equivalents (MME)

During the 48 hours after CRS-HIPEC surgery

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Secondary

Comparison of the Length of Stay (LOS) Between Patients With 4Q-TAP Versus TEA

Length of stay calculated from day of surgery to date of hospital discharge.

Posted

Median

Full Range

days

Length of stay calculated from day of surgery to date of hospital discharge, up to 46 days

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	4Q-TAP Blocks	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Secondary

Number of Participants With Adverse Events Related to 4Q-TAP Versus TEA

An adverse event is any symptom, sign, illness, or experience which develops or worsens during the course of the study, whether or not the event is considered related to study drug. Adverse events (AEs) related to the study interventions recorded within the first 48 hours after the end of surgery.

Posted

Count of Participants

Participants

48 hours after CRS-HIPEC surgery

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Secondary

Number of Participants With Incidence of Opioid-Related Adverse Events Related to 4Q-TAP Versus TEA 48

Opioid-related adverse (i.e. respiratory depression, pruritus, sedation, delirium) within the first 48 hours after the end of surgery.

Posted

Count of Participants

Participants

Within the first 48 hours after the end of CRS-HIPEC surgery

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

Secondary

Number of Participants With Incidence of Postoperative Complications and Morbidity in Patients Receiving 4Q-TAP Versus TEA

Postoperative complications recorded using Clavien-Dindo scale and POMS.

Posted

Count of Participants

Participants

48 hours after CRS-HIPEC surgery

ID	Title	Description
OG000	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.
OG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.

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	Standard-of-Care Thoracic Epidural Analgesia (TEA)	Participants allocated to the TEA group had an epidural catheter placed before induction of anesthesia. The catheter was placed between the thoracic vertebral spaces 8 and 12 according to standard procedure. A bolus or infusion of local anesthetic solution with or without the addition opioids (bupivacaine 0.075% ± hydromorphone 2-5 mcg/mL or bupivacaine 0.075% ± fentanyl 5 mcg/mL, basal rate 8 mL/h, bolus 3 mL every 10 min) were given before surgical incision according to the anesthesiologist's clinical judgment. If deemed appropriate, a precision epidural bolus of hydromorphone (300-800 micrograms) was administered.	0	33	0	33	17	33
EG001	Four Quadrant Transverse Abdominus Plane (4Q-TAP) Block	Participants in 4Q-TAP group received maximum of 80. cc of a solution consisting of 150 mg of bupivacaine HCl and 266 mg of liposomal bupivacaine divided between each of the four quadrants after induction of anesthesia. All 4Q-TAP were done after induction of general anesthesia and under ultrasound guidance.	0	35	1	35	16	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intraabdominal Abscess	General disorders	CTCAE (4.0)	Systematic Assessment		EG0000 affected33 at risk EG0011 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0014 affected35 at risk
Hypotension	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected33 at risk EG0018 affected35 at risk
Ileus	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected35 at risk
Low urinary input	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0011 affected35 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected33 at risk EG00116 affected35 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0013 affected35 at risk
Sedation	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0010 affected35 at risk

First MCP Posted Date

ID	Term
D002045	Bupivacaine

Units	Counts
Participants	OG00033 OG00135

Units	Counts
Participants	OG00033 OG00135

Units	Counts
Participants	OG00033 OG00135

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines