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

Phase 3

• Conditions: Pain, Postoperative; ACL
• Interventions: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Tylenol Pill; Drug: Liposomal bupivacaine; Procedure: Femoral Nerve Catheter

• Registration Number: NCT05161221
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-03
• Study Start: 2021-12-06
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-operative adductor canal block with liposomal bupivacaine	Naproxen 500 Mg	participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Pre-operative femoral nerve catheter	Tylenol Pill	participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Pre-operative adductor canal block with liposomal bupivacaine	Tylenol Pill	participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Pre-operative femoral nerve catheter	OxyCODONE 5 mg Oral Tablet	participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Pre-operative adductor canal block with liposomal bupivacaine	OxyCODONE 5 mg Oral Tablet	participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Pre-operative adductor canal block with liposomal bupivacaine	Liposomal bupivacaine	participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
Pre-operative femoral nerve catheter	Femoral Nerve Catheter	participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
Pre-operative femoral nerve catheter	Naproxen 500 Mg	participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	8 weeks	Participant will record Patient Satisfaction through Visual Analog Scale for pain
Post operative pain management	8 weeks	Participant will record quadriceps function tests

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States