Recruitment

Recruitment Status
Completed
Estimated Enrollment
Same as current

Summary

Conditions
  • Analgesia
  • Postsurgical Pain
  • Prostatectomy
Type
Interventional
Phase
Phase 4
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Only males

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 infilt...

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.

Tracking Information

NCT #
NCT01582477
Collaborators
Not Provided
Investigators
Principal Investigator: Andrew Sternlicht, MD Steward St. Elizabeth's