Exparel Versus Bupivacaine in Post-operative Pain Control

June 30, 2026 updated by: Case Western Reserve University

Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial

This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this prospective, randomized study was to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. At the end of the third molar extraction surgical procedure and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), patients will, at random, receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) or with standard 3mL standard bupivacaine. Electronic home questionnaires will be completed by the patient following the procedure for 96 hours to evaluate these clinical parameters

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars.

Exclusion Criteria:

  • history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: liposomal bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
Drug: Bupivacaine liposome injectable suspension
At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
Other Names:
  • standard bupivacaine
Active Comparator: standard bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.
Drug: Bupivacaine liposome injectable suspension
At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
Other Names:
  • standard bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Pain Intensity (Visual Analog Scale VAS)
Time Frame: Twice daily (morning and evening) from 0-96 hours post-operatively
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire
Twice daily (morning and evening) from 0-96 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative NSAID/Acetaminophen Consumption
Time Frame: Daily from 0 to 96 hours post-operatively
Post operative analgesic consumption was recorded using a standardized at home questionnaire. Patients document the number of NSAIDS (Ibuprofen 600mg) and Acetaminophen tablets taken daily for four consecutive postoperative days.
Daily from 0 to 96 hours post-operatively
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
Time Frame: daily from 0 to 96 hours post-operatively
post operative opioid consumption was recorded using a standardized at home qusetionnaire. patients documented the number of (Hydrocodone-Acetaminophen 5/325) tablets taken daily for four consecutive postoperative days
daily from 0 to 96 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Faisal Quereshy, MD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20221478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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