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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

An envelope, which is identified by the patient specific study ID, will contain Exparel and standard bupivacaine syringes. The syringes will be masked and labeled left or right, depending on the randomization results. Designated dental assistants not associated with the study will receive the corresponding envelope to prepare the syringes. Syringes containing the solutions will be masked so that the operator would not be able to detect which solution is being infiltrated.

Study Groups

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Liposomal bupivacaine

A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the mandibular third molar extraction surgical procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel).

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

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 1:200,000 epinephrine

A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine.

Group Type ACTIVE_COMPARATOR

0.5% bupivacaine with 1:100,000 epinephrine

Intervention Type DRUG

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.

Interventions

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Liposomal bupivacaine

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.

Intervention Type DRUG

0.5% bupivacaine with 1:100,000 epinephrine

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes