NCT06006624

Exparel vs Block for ACL Reconstruction

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• ACL
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Exparel 30 mL	30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
DRUG	0.5% bupivacaine	5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
DRUG	Dexamethasone	10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
DRUG	iPACK block	iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Timeline

• Start date: 2023-08-21
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2023-08-23
• Last updated: 2024-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study