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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am having ACL reconstruction with my own tissue, possibly with meniscus surgery or extra tendon support.
Select...
My ACL injury is suitable for surgery using my own tissue, as confirmed by a surgeon.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative Pain
Postoperative Pain #2
Postoperative opioid use
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)
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Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,424 Total Patients Enrolled
2 Trials studying Postoperative Pain
369 Patients Enrolled for Postoperative Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Group 1: ACL repair + Exparel + nerve block a safe and reliable procedure for individuals?
"The safety of ACL repair + Exparel + nerve block is rated a 3 on the 1-3 scale as it has passed Phase 4, signifying that this treatment is approved."
Answered by AI
Can individuals still participate in this experiment?
"The clinical trial, initially posted on August 21st 2023 and last revised a day later, is not currently seeking additional patients. However, there are an abundant 567 other trials actively recruiting individuals at this time."
Answered by AI
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