Clinical trial NCT06547255: Exparel Versus Bupivacaine in Post-operative Pain Control
Official title: Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liposomal Bupivacaine
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: post operative pain
timeFrame: 96 hours post-operatively
measure: Adverse effects
timeFrame: 96 hours post-operatively
measure: NSAID/Acetaminophen use
timeFrame: 96 hours post-operatively
measure: Norco 5/325 (Hydrocone-Acetaminophen) Use
timeFrame: 96 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Faisal Quereshy, MD
role: PRINCIPAL_INVESTIGATOR
References: