Conditions: Postsurgical Pain Analgesia Prostatectomy
Keywords: TAP, robot-assisted prostatectomy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. arm 2: 20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.

Interventions: intervention 1: EXPAREL 20 mL intervention 2: EXPAREL 40 mL
Intervention descriptions: intervention 1: EXPAREL 266 mg (undiluted) intervention 2: EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Protocol document: