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

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

Conditions: ACL; Pain, Postoperative

Treatments: Procedure: Femoral Nerve Catheter; Drug: Tylenol Pill; Drug: Liposomal bupivacaine; Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05161221

sham21D.369

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients undergoing primary anterior cruciate ligament reconstruction with autograft
2. Has not used narcotic pain medication in 3 months
3. Ages of 18+
4. Proficient in the English language
5. Willing and able to follow study protocol

Exclusion criteria

1. ACL repair, revision surgery, or allograft
2. Multi-ligamentous knee injuries
3. Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
4. Patients taking baseline opioid for other injury
5. Dementia or other psychiatric illness that would preclude accurate evaluation
6. Pregnant or lactating patients
7. Non-English speakers as questionnaires are only available in English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Pre-operative femoral nerve catheter

Active Comparator group

Description:

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Drug: Naproxen 500 Mg

Drug: Tylenol Pill

Procedure: Femoral Nerve Catheter

Pre-operative adductor canal block with liposomal bupivacaine

Active Comparator group

Description:

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Drug: Naproxen 500 Mg

Drug: Liposomal bupivacaine

Drug: Tylenol Pill