Exparel for Postoperative Pain in ACL Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Rothman Institute Orthopaedics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who can consent, speak English, and complete surveys. It's for those needing primary ACL reconstruction with a specific graft type after an ACL rupture. People with allergies to the medications used in the study, prior opioid use, or complex knee injuries are not eligible.

Inclusion Criteria

English speaking

I am having ACL reconstruction with my own tissue, possibly with meniscus surgery or extra tendon support.

Ability to complete surveys by phone or in person

+3 more

Exclusion Criteria

I have multiple ligament injuries in my knee.

Non-English speakers

I had ACL surgery with a graft not from my kneecap tendon.

+6 more

Participant Groups

The trial tests Exparel against iPACK block for managing pain after ACL surgery. Exparel is a long-lasting analgesic approved for nerve blocks that may provide up to 72 hours of pain relief following ACL reconstruction.

2Treatment groups

Active Control

Group I: Group 2: ACL repair + Exparel + Dexamethasone + nerve blockActive Control4 Interventions

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 II: Group 1: ACL repair + Exparel + nerve blockActive Control3 Interventions

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)