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Completed

NCT Number: NCT06547255

Exparel Versus Bupivacaine in Post-operative Pain Control

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Other names: standard bupivacaine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jul 28, 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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