CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 85 enrolled / 85 target
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Liposomal bupivacaine 3 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05374499
NCT05374499Phase 4CompletedHigh Momentum (1.9/mo)Completion was 31mo ago
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Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions

University of Southern California·interventional·Posted May 16, 2022·Updated Jun 4, 2026

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine and 0.5% bupivacaine with 1:100,000 epinephrine for Post Operative Pain. Completed, enrolled 85 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Operative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMay 16, 2022
Enrollment StartSep 1, 2022
Primary CompletionDec 1, 2023
Study CompletionMay 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.1 years ago

Arms & Interventions

Liposomal bupivacaineexperimental

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).

Drug: Liposomal bupivacaine
0.5% bupivacaine with 1:200,000 epinephrineactive_comparator

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.

Drug: 0.5% bupivacaine with 1:100,000 epinephrine

Interventions

Liposomal bupivacainedrug

Dosage: 3 mL Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.

0.5% bupivacaine with 1:100,000 epinephrinedrug

Dosage: 3 mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine (2:1 ratio of saline to standard bupivacaine) Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.