NCT03428984

Study in Adult Subjects Undergoing Posterolateral Thoracotomy

A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of EXPAREL When Administered for Postsurgical Analgesia in Subjects Undergoing Posterolateral Thoracotomy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block. Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model.

Detailed description

This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXPAREL when administered as a posterior intercostal nerve block. Twenty-four adult subjects undergoing thoracotomy are planned for enrollment. Subjects will be screened within 30 days prior to study drug administration. During the screening visit, which must take place at least 1 day prior to surgery, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation. Subjects will undergo their pre-planned thoracotomy procedure per the institution's standard of care. Prior to wound closure, subjects will be given either 40 mL of study drug (20 mL EXPAREL expanded with 20 mL normal saline) or 30 mL of study drug (20 mL EXPAREL expanded with 10 mL normal saline). Subjects will remain in the hospital for a minimum of 48 hours for pharmacokinetic testing and evaluation of safety. On Day 14, the subject will complete the study via phone call in order to collect safety data.

Conditions

• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	EXPAREL	EXAPREL 266 mg in 20 mL

Timeline

• Start date: 2018-05-03
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2018-02-12
• Last updated: 2019-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study