Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions

University of Southern California85 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Post Operative Pain

Interventions

Liposomal bupivacaineDRUG

Dosage: 3 mL Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.

0.5% bupivacaine with 1:100,000 epinephrineDRUG

Dosage: 3 mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine (2:1 ratio of saline to standard bupivacaine) Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Post-operative Pain

At home questionnaire with a numerical scale (0 - 10 with 0 being least amount of pain and 10 being most amount of pain), to be completed each morning and evening for four days post-operative. Then the cumulative pain rating using the numeric rating scale area under the curve over 96 hours (0 - 960 with 0 being least amount of pain over 96 hours and 960 being the most amount of pain over 96 hours), scaled at the hour-level, is calculated using the trapezoidal method in the caTools package in R, which is a sum of the averages of the numeric rating scale. A higher value is a worse outcome and lower value is a better outcome.

Time frame: Mean Area under Curve Numeric rating scale scores 96 hours post-operatively

Secondary Outcomes

NSAID/Acetaminophen Use

Number of Participants with NSAID/Acetaminophen Use

Time frame: 96 hours post-operatively

Oxycodone Use

Number of Participants with oxycodone Use