Exparel Versus Bupivacaine in Post-operative Pain Control

NCT06547255 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY20221478
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain Intensity (Visual Analog Scale VAS)

  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 Outcomes (2)

• Post Operative NSAID/Acetaminophen Consumption

  Daily from 0 to 96 hours post-operatively

• Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use

  daily from 0 to 96 hours post-operatively

Study Arms (2)

standard bupivacaine

ACTIVE COMPARATOR

patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.

Drug: Bupivacaine liposome injectable suspension

liposomal bupivacaine

EXPERIMENTAL

patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)

Drug: Bupivacaine liposome injectable suspension

Interventions

Bupivacaine liposome injectable suspension DRUG

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.

Also known as: standard bupivacaine

liposomal bupivacaine; standard bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Limitations and Caveats

This study have several limitations: * Operators were not blinded to group allocation which may introduce performance bias * Surgical difficulty and procedure duration were not standardized and may have varied between participants * Procedure has been performed by residents at different level of training which may have influenced outcomes * Baseline difference in ASA Physical status were present between the study groups

Results Point of Contact

• Title: Mohammed Louay Taifour, DMD
• Organization: Case Western Reserve University

mmt51@case.edu

440-749-7865

Study Officials

• Faisal Quereshy, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 21, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 28, 2026
• Results First Posted: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)