NCT01582477

TAP-patients With Robotic Assisted Lap Prostatectomy

Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

Detailed description

Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.

Conditions

• Postsurgical Pain
• Analgesia
• Prostatectomy

Interventions

Type	Name	Description
DRUG	EXPAREL 20 mL	EXPAREL 266 mg (undiluted)
DRUG	EXPAREL 40 mL	EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2012-04-20
• Last updated: 2021-06-14
• Results posted: 2013-06-10

Locations

1 site across 1 country: United States