Exparel vs Block for ACL Reconstruction

Study Overview
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Brief Summary
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Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.

Official Title
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Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

Conditions
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ACL, Postoperative Pain

Intervention / Treatment
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* Drug: Exparel 30 mL
* Drug: 0.5% bupivacaine
* Drug: Dexamethasone
* Drug: iPACK block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis Age 18 and older English speaking Ability to complete surveys by phone or in person Ability to provide informed consent Exclusion Criteria: Revision cases Multi-ligamentous knee injuries Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol ACL reconstruction utilizing non-bone-patellar tendon-bone autografts Allergies to study medications Non-English speakers Known alcohol or narcotic abuse history Existing contract with a pain specialist due to underlying preoperative pain syndrome Preoperative opioid use within the 3 months prior to surgery

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: ACL repair + Exparel + nerve block<br>30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total) | Drug: Exparel 30 mL<br>* 30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block<br>Drug: 0.5% bupivacaine<br>* 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal<br>Drug: iPACK block<br>* iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block<br>|
| Active Comparator: Group 2: ACL repair + Exparel + Dexamethasone + nerve block<br>30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total) | Drug: Exparel 30 mL<br>* 30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block<br>Drug: 0.5% bupivacaine<br>* 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal<br>Drug: Dexamethasone<br>* 10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal<br>Drug: iPACK block<br>* iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain | 14 days | 
| Postoperative opioid use | assessed using a participant daily diary of how much medication was taken daily for pain | 14 days | 
| Postoperative Pain #2 | Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain | 14 days |