Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial

Status: Enrolling by invitation
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity. No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias. The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Patients undergoing primary anterior cruciate ligament reconstruction with autograft

• Has not used narcotic pain medication in 3 months

• Ages of 18+

• Proficient in the English language

• Willing and able to follow study protocol

Locations
United States
Pennsylvania
Rothman Orthopaedic Institute
Philadelphia
Time Frame
Start Date: December 6, 2021
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 154
Treatments
Active Comparator: Pre-operative femoral nerve catheter
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Active Comparator: Pre-operative adductor canal block with liposomal bupivacaine
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Related Therapeutic Areas
Sponsors
Leads: Rothman Institute Orthopaedics

This content was sourced from clinicaltrials.gov