TAP-patients With Robotic Assisted Lap Prostatectomy

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

male subjects, aged 18-75.
American Society of Anesthesiology (ASA) physical status 1-3.
Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
Subjects must be physically and mentally able to participate in the study and complete all study assessments.
Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.

Exclusion Criteria

Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP.
Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
Subjects who have received any investigational drug within 30 days prior to study drug administration or planned administration of another investigational product or procedure during their participation in this study.

Arm && Interventions

Group	Intervention	Description
EXPAREL 20 mL (undiluted)	EXPAREL 20 mL	20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.
EXPAREL 40 mL (diluted)	EXPAREL 40 mL	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.

Primary Outcome Measures

Name	Time	Method
The Duration of Abdominal Analgesia From Infiltration Into the TAP	First postsurgical administration of an opioid

Secondary Outcome Measures

Name	Time	Method
Subject Reported Postsurgical Pain	1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP	11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Physician/Healthcare Professional Assessed Postsurgical Pain	1, 2, 6, 12, 24 hours after TAP	11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.	48, 72, 96 hours	Number of pills
Incidence of Prespecified Opioid-related Adverse Events	Until hospital discharge order was written, anticipated at 24 hours.	Number of subjects
Overall Rating of Subject Satisfaction With Postsurgical Pain Control	24 hours, 72 hours, and day 10	Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)