NCT05161221

Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative
• ACL

Interventions

Type	Name	Description
DRUG	OxyCODONE 5 mg Oral Tablet	Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
DRUG	Naproxen 500 Mg	Participant will receive Naproxen 500 Mg post surgery for pain control
DRUG	Tylenol Pill	Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
DRUG	Liposomal bupivacaine	Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
PROCEDURE	Femoral Nerve Catheter	Participants will receive pre-operative femoral nerve catheter

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-12-17
• Last updated: 2021-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study