Exparel Versus Bupivacaine in Post-operative Pain Control

NCT06547255 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY20221478
• Study Type: interventional
• Target: 82
• 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 (4)

• 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

• 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

• 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

Study Arms (2)

standard bupivicaine

ACTIVE COMPARATOR

patient receive mandibular and maxillary infiltrations with 3mL of standard 3mL 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 bupivicaine

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

Study Officials

• Faisal Quereshy, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

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: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)