TAP-patients With Robotic Assisted Lap Prostatectomy (TAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Prostatectomy; Postsurgical Pain
• Intervention / Treatment: Drug: EXPAREL 20 mL; Drug: EXPAREL 40 mL

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Steward St. Elizabeth's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPAREL 20 mL (undiluted); 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.	Drug: EXPAREL 20 mL; EXPAREL 266 mg (undiluted); Other Names: bupivacaine liposome injectable suspension
Active Comparator: EXPAREL 40 mL (diluted); 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.	Drug: EXPAREL 40 mL; EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.; Other Names: bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Duration of Abdominal Analgesia From Infiltration Into the TAP	First postsurgical administration of an opioid

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Reported Postsurgical Pain	11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)	1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Physician/Healthcare Professional Assessed Postsurgical Pain	11-point NRS (0-10, 0=no pain, 10=worst possible pain)	1, 2, 6, 12, 24 hours after TAP
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.	Number of pills	48, 72, 96 hours
Incidence of Prespecified Opioid-related Adverse Events	Number of subjects	Until hospital discharge order was written, anticipated at 24 hours.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control	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)	24 hours, 72 hours, and day 10

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Andrew Sternlicht, MD, Steward St. Elizabeth's

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: TAP, robot-assisted prostatectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MA402S23B701