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

Study Overview
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Brief Summary
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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.

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

Conditions
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ACL, Pain, Postoperative

Intervention / Treatment
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* Drug: OxyCODONE 5 mg Oral Tablet
* Drug: Naproxen 500 Mg
* Drug: Tylenol Pill
* Drug: Liposomal bupivacaine
* Procedure: Femoral Nerve Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: ACL repair, revision surgery, or allograft Multi-ligamentous knee injuries Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol Patients taking baseline opioid for other injury Dementia or other psychiatric illness that would preclude accurate evaluation Pregnant or lactating patients Non-English speakers as questionnaires are only available in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-operative femoral nerve catheter<br>participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery | Drug: OxyCODONE 5 mg Oral Tablet<br>* Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control<br>Drug: Naproxen 500 Mg<br>* Participant will receive Naproxen 500 Mg post surgery for pain control<br>Drug: Tylenol Pill<br>* Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control<br>Procedure: Femoral Nerve Catheter<br>* Participants will receive pre-operative femoral nerve catheter<br>* Other names: Femoral Nerve Block;|
| Active Comparator: Pre-operative adductor canal block with liposomal bupivacaine<br>participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel) | Drug: OxyCODONE 5 mg Oral Tablet<br>* Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control<br>Drug: Naproxen 500 Mg<br>* Participant will receive Naproxen 500 Mg post surgery for pain control<br>Drug: Tylenol Pill<br>* Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control<br>Drug: Liposomal bupivacaine<br>* Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Participant will record Patient Satisfaction through Visual Analog Scale for pain | 8 weeks | 
| Post operative pain management | Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments. | 8 weeks | 
| Post operative pain management | Participant will record quadriceps function tests | 8 weeks |