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

NCT05374499 | Completed Phase 4 FDA Drug

• 1 other identifier: APP2200106
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Adverse effects

  96 hours post-operatively

• NSAID/Acetaminophen Use

  96 hours post-operatively

• Oxycodone Use

  96 hours post-operatively

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

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).

Drug: Liposomal bupivacaine

0.5% bupivacaine with 1:200,000 epinephrine

ACTIVE COMPARATOR

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.

Drug: 0.5% bupivacaine with 1:100,000 epinephrine

Interventions

Liposomal bupivacaine 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.

Liposomal bupivacaine

0.5% bupivacaine with 1:100,000 epinephrine 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.

0.5% bupivacaine with 1:200,000 epinephrine

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Herman Ostrow School of Dentistry of USC

Los Angeles, California, 90089, United States

Location

Related Publications (1)

• 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.

  PMID: 28858553 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)