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Local Anesthetic

Bupivacaine and Liposomal Bupivacaine for Postoperative Pain

Phase 4

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 hours post-operatively

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

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.

Eligible Conditions

Postoperative Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Post-operative pain

Secondary study objectives

Adverse effects

Anti-Inflammatory Agents, Non-Steroidal

Oxycodone Use

Awards & Highlights

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.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal bupivacaineExperimental Treatment1 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 epinephrineActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal bupivacaine

2016

Completed Phase 4

~1970

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