Clinical trial NCT05374499: Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions
Official title: Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 73
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.

Detailed description: In this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with Exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of Exparel in reducing postoperative pain. Outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of NSAID or acetaminophen outside of prescribed pain regimen, and use of narcotics. The purpose of this research project is to evaluate the use and efficacy of Exparel in postoperative pain management in third molar extractions.

Eligibility criteria: Inclusion Criteria:

* Patients receiving bilateral mandibular third molar extractions at the Herman Ostrow School of Dentistry by an oral \& maxillofacial surgery resident.

Exclusion Criteria:

* Patient unable to complete form for four days postoperatively.
* Patient with severe hepatic disease
* Patient with a history of allergy or contraindication to amide-type LA or opioids
* Patient with recent history of antibiotic use within the past thirty days
* Patients with use of long-acting opioids, NSAIDs, aspirin, acetaminophen within 3 days prior to screening.
* Patients who are pregnant.
* Patients receiving additional mandibular teeth extractions.

Primary outcomes:
measure: Post-operative pain
timeFrame: 96 hours post-operatively
Secondary outcomes:
measure: Adverse effects
timeFrame: 96 hours post-operatively
measure: NSAID/Acetaminophen Use
timeFrame: 96 hours post-operatively
measure: Oxycodone Use
timeFrame: 96 hours post-operatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Herman Ostrow School of Dentistry of USC
state: California
Study officials:
References:
citation: Lieblich SE, Danesi H. Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study. Anesth Prog. 2017 Fall;64(3):127-135. doi: 10.2344/anpr-64-02-03.