TAP-patients With Robotic Assisted Lap Prostatectomy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postsurgical Pain Analgesia Prostatectomy	Drug: EXPAREL 20 mL Drug: EXPAREL 40 mL	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

The Duration of Abdominal Analgesia From Infiltration Into the TAP [ Time Frame: First postsurgical administration of an opioid ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	24
Study Start Date:	March 2012
Study Completion Date:	July 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: bupivacaine liposome injectable suspension

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582477

Locations

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

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

Principal Investigator:

Andrew Sternlicht, MD

Steward St. Elizabeth's

More Information

No publications provided

Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01582477 History of Changes
Other Study ID Numbers:	MA402S23B701
Study First Received:	April 19, 2012
Results First Received:	February 26, 2013
Last Updated:	May 5, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

TAP, robot-assisted prostatectomy

Additional relevant MeSH terms:

Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013