Exparel vs Block for ACL Reconstruction

Phase 4

• Conditions: Postoperative Pain; ACL
• Interventions: Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: Dexamethasone; Drug: iPACK block

• Registration Number: NCT06006624
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-17
• Study Start: 2023-08-21
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: ACL repair + Exparel + Dexamethasone + nerve block	iPACK block	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)
Group 1: ACL repair + Exparel + nerve block	Exparel 30 mL	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)
Group 1: ACL repair + Exparel + nerve block	0.5% bupivacaine	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)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block	Dexamethasone	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)
Group 1: ACL repair + Exparel + nerve block	iPACK block	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)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block	Exparel 30 mL	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)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block	0.5% bupivacaine	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

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