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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05374499
• Other study ID #: APP2200106
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Herman Ostrow School of Dentistry of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse effects	At home questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache.	96 hours post-operatively
Secondary	NSAID/Acetaminophen Use	At home questionnaire including the dosage, time, quantity and reason for use.	96 hours post-operatively
Secondary	Oxycodone Use	At home questionnaire including the dosage, time, quantity and reason for use.	96 hours post-operatively