NCT02517905

Evaluation of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Local Administration of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled to undergo elective bilateral third molar extraction under local anesthesia. At least one lower mandibular third molar must involve full or partial bony impaction confirmed by visual or radiographic evidence.

Detailed description

Subjects will be screened within 30 days prior to surgery. Randomized subjects will receive a dental nerve block with lidocaine 2% with epinephrine 1:100,000 before undergoing bilateral third molar extraction under local anesthesia. In addition to the lidocaine nerve block, the Investigator may choose to add topical benzocaine or intraoperative nitrous oxide. At the end of surgery, and at least 20 minutes after the lidocaine administration, blinded study drug will be infiltrated to provide postsurgical analgesia. Subjects will be required to remain in the research facility for 96 hours after study drug administration. Postsurgical efficacy, safety, and pharmacokinetic (PK) assessments will be conducted. All subjects will return for a follow-up visits on Days 7 and 10. A phone call will be made to each subject on Day 30 for an adverse event (AE) assessment and to inquire as to whether the subject made any unscheduled phone calls or office visits related to pain.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine liposome	Local administration
DRUG	Placebo	Local administration

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-08-07
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

1 site across 1 country: United States