Exparel Versus Bupivacaine in Post-operative Pain Control

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: Liposomal Bupivacaine
• Intervention / Treatment: Drug: Bupivacaine liposome injectable suspension

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): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard bupivicaine; patient receive mandibular and maxillary infiltrations with 3mL of standard 3mL 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	At home questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache.	96 hours post-operatively
post operative pain	At home questionnaire with a numerical scale (0 - 10), to be completed each morning and evening for four days post-operative	96 hours post-operatively
NSAID/Acetaminophen use	Ibuprofen 600mg [Advil], Tylenol) Use	96 hours post-operatively
Norco 5/325 (Hydrocone-Acetaminophen) Use	At home questionnaire including the dosage, time, quantity and reason for use	96 hours post-operatively

Collaborators and Investigators

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

Study record dates

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): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• 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