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Exparel for Postoperative Pain in ACL Surgery

Phase 4

Waitlist Available

Research Sponsored by Rothman Institute Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis

Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons

Must not have

Multi-ligamentous knee injuries

ACL reconstruction utilizing non-bone-patellar tendon-bone autografts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial studied the use of an extended-release form of an anesthetic called Exparel to provide pain relief after surgery. It showed promise in knee surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions at the injection site such as pain or swelling, possible nerve damage risks associated with regional anesthesia, and general side effects like nausea or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My ACL injury is suitable for surgery using my own tissue, as confirmed by a surgeon.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have multiple ligament injuries in my knee.

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

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I've had knee surgery that stops me from putting weight on it right away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative Pain

Postoperative Pain #2

Postoperative opioid use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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)

0 / 6Eligibility criteria met