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TAP-patients With Robotic Assisted Lap Prostatectomy (TAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582477
First Posted: April 20, 2012
Last Update Posted: June 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
  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
Intervention Model: Single Group Assignment
Masking: None (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

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 ]

Secondary Outcome Measures:
  • Subject Reported Postsurgical Pain [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 48, 72, 96 hours, and 10 days ]
    Number of pills

  • Incidence of Prespecified Opioid-related Adverse Events [ Time Frame: Until hospital discharge order was written, anticipated at 24 hours. ]
    Number of subjects

  • Overall Rating of Subject Satisfaction With Postsurgical Pain Control [ Time Frame: 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)


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01582477     History of Changes
Other Study ID Numbers: MA402S23B701
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: February 26, 2013
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013
Last Verified: May 2013

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
Sensory System Agents
Peripheral Nervous System Agents