Exparel vs Block for ACL Reconstruction

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 4

Conditions: Postoperative Pain; ACL

Treatments: Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: iPACK block; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06006624

SHAM2023-2163

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Group 1: ACL repair + Exparel + nerve block

Active Comparator group

Description:

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)

Treatment:

Drug: iPACK block

Drug: 0.5% bupivacaine

Drug: Exparel 30 mL

Group 2: ACL repair + Exparel + Dexamethasone + nerve block

Active Comparator group

Description:

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)

Treatment:

Drug: Dexamethasone

Drug: iPACK block

Drug: 0.5% bupivacaine

Drug: Exparel 30 mL