Trial Evaluating Postop Pain and Muscle Strength Among Re... | NCT02584452

NCT02584452

Status Module

Oversight Module

Description 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
Continuous Adductor Canal Nerve Catheter	Active Comparator	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.	Drug: Mepivacaine Procedure: adductor canal continuous nerve catheter Drug: Normal Saline as bolus followed by bupivacaine Drug: Propofol Drug: Fentanyl
Long Acting Single Bolus Adductor Canal Nerve Block	Active Comparator	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.	Drug: Mepivacaine Procedure: adductor canal nerve block Drug: ropivacaine and dexamethasone Drug: Propofol Drug: Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepivacaine	Drug	20cc of 2% mepivacaine <20 minutes prior to in room time.	Continuous Adductor Canal Nerve Catheter Long Acting Single Bolus Adductor Canal Nerve Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU.	Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).	Post Operative Day 2
Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU	Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).	Post Operative Day 1

Secondary Outcomes

Measure	Description	Time Frame
Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block	Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).

Eligibility Module

Name	Affiliation	Role
Christopher Sobey, MD	Vanderbilt University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37212	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11172507	Background	Mulroy MF, Larkin KL, Batra MS, Hodgson PS, Owens BD. Femoral nerve block with 0.25% or 0.5% bupivacaine improves postoperative analgesia following outpatient arthroscopic anterior cruciate ligament repair. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):24-9. doi: 10.1053/rapm.2001.20773.
20889937	Background	Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Patients then undergo general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction with propofol bolus and placement of laryngeal mask airway. Intraoperative opioid limited to no > 150mcg of fentanyl. Completion of procedure, dressing and LMA revoved with patients transferred to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Aug 23, 2017

Arm/Group Information

ID	Title	Description
BG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
BG001	Long Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00121 BG00253

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
0 (Pain on Subjective Numeric Pain Scale)	OG0001 OG0011
1 (Pain on Subjective Numeric Pain Scale)	OG000

Primary

Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU

Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).

Data was unavailable for 1 participant in both groups.

Posted

Count of Participants

Participants

Post Operative Day 1

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block

Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).

Posted

Count of Participants

Participants

Post Operative Day 1

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.

Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.

Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative days 2 and 3.

Posted

Count of Participants

Participants

Post Operative Day 2 and 3

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter.

Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).

Data was unavailable for 1 participant in each group.

Posted

Count of Participants

Participants

Post Operative Week 6

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)

Data was unavailable for 1 participant in both groups.

Posted

Count of Participants

Participants

Post Operative Day 1

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
OG001	Long-Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv

Secondary

Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block

Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain).

Data was unavailable for 1 participant in each group.

Posted

Count of Participants

Participants

Post Operative Week 6

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain

Data was unavailable for 1 participant in each group.

Posted

Count of Participants

Participants

Post Operative Week 6

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
OG001	Long-Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv

Secondary

Postoperative Nausea and Vomiting

Postoperative nausea and vomiting score on POD 1 following discharge from PACU

Posted

Count of Participants

Participants

POD 1 following discharge from PACU

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
OG001	Long-Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv

Secondary

Subjective Assessment of Experience With Analgesia

Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations

Data was unavailable for 1 participant in each group.

Posted

Count of Participants

Participants

Post Operative Week 6

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
OG001	Long-Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv

Secondary

Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block

Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).

Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative day 3.

Posted

Count of Participants

Participants

Post Operative Day 3

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal

Secondary

Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.

Posted

Count of Participants

Participants

Post Operative Day1

ID	Title	Description
OG000	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal
OG001

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	Continuous Adductor Canal Nerve Catheter	Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal	0	34	0	34	3	34
EG001	Long Acting Single Bolus Adductor Canal Nerve Block	Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv	0	23	0	23	4	23

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Leaking from insertion site	Surgical and medical procedures	Non-systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected23 at risk
Knee effusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected23 at risk
Inflamed esophagus	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected23 at risk
Heartburn	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected23 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected23 at risk
Deep Vein Thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected23 at risk
Dizziness	General disorders	Non-systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected23 at risk

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

ID	Term
D008619	Mepivacaine
D000077330	Saline Solution
D002045	Bupivacaine
D000077212	Ropivacaine
D003907	Dexamethasone
D015742	Propofol
D005283	Fentanyl