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Completed

NCT Number: NCT05374499

Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herman Ostrow School of Dentistry of USC

Los Angeles, California, 90089, United States

About this study

In this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with Exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of Exparel in reducing postoperative pain. Outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of NSAID or acetaminophen outside of prescribed pain regimen, and use of narcotics. The purpose of this research project is to evaluate the use and efficacy of Exparel in postoperative pain management in third molar extractions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients receiving bilateral mandibular third molar extractions at the Herman Ostrow School of Dentistry by an oral & maxillofacial surgery resident.

Exclusion criteria

  • Patient unable to complete form for four days postoperatively.
  • Patient with severe hepatic disease
  • Patient with a history of allergy or contraindication to amide-type LA or opioids
  • Patient with recent history of antibiotic use within the past thirty days
  • Patients with use of long-acting opioids, NSAIDs, aspirin, acetaminophen within 3 days prior to screening.
  • Patients who are pregnant.
  • Patients receiving additional mandibular teeth extractions.

Treatment and study plan

Liposomal bupivacaine

Drug

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 epinephrine

Drug

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.

Primary outcomes

  1. Post-operative Pain

    Time frame: Mean Area under Curve Numeric rating scale scores 96 hours post-operatively

    At home questionnaire with a numerical scale (0 - 10 with 0 being least amount of pain and 10 being most amount of pain), to be completed each morning and evening for four days post-operative. Then the cumulative pain rating using the numeric rating scale area under the curve over 96 hours (0 - 960 with 0 being least amount of pain over 96 hours and 960 being the most amount of pain over 96 hours), scaled at the hour-level, is calculated using the trapezoidal method in the caTools package in R, which is a sum of the averages of the numeric rating scale. A higher value is a worse outcome and lower value is a better outcome.

Secondary outcomes

  1. NSAID/Acetaminophen Use

    Time frame: 96 hours post-operatively

    Number of Participants with NSAID/Acetaminophen Use

  2. Oxycodone Use

    Time frame: 96 hours post-operatively

    Number of Participants with oxycodone Use

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 16, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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