Bupivacaine and Liposomal Bupivacaine for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new pain relief medication called liposomal bupivacaine (Exparel) for people having their wisdom teeth removed. The medication is injected at the surgery site and slowly releases pain relief over time. The goal is to see if it reduces pain and the need for stronger painkillers better than standard treatments. Liposomal bupivacaine (Exparel) is a local analgesic that has been shown to reduce pain in various surgical procedures.

Eligibility Criteria

Inclusion Criteria

You are having surgery to remove both of your back wisdom teeth at a specific dental school.

Exclusion Criteria

Patients who are pregnant.

You have a serious liver disease.

Patient unable to complete form for four days postoperatively.

Treatment Details

Interventions

• 0.5% bupivacaine with 1:100,000 epinephrine (Local Anesthetic)
• Liposomal bupivacaine (Local Anesthetic)

Participant Groups

Group I: Liposomal bupivacaine Experimental Treatment 1 Intervention

A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the mandibular third molar extraction surgical procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel).

Group II: 0.5% bupivacaine with 1:200,000 epinephrine Active Control 1 Intervention

A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine.

Liposomal bupivacaine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Exparel for:

• Postsurgical pain in adults

🇪🇺 Approved in European Union as Exparel liposomal for:

• Local pain relief around small to medium-sized surgical wounds
• Regional pain relief in the surgery of the knee and around the shoulders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Herman Ostrow School of Dentistry of USC Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

References