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Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 29, 2011
Last updated: July 18, 2016
Last verified: July 2016
This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.

Condition Intervention Phase
Gynecologic Cancer Post-operative Pain Drug: Bupivicaine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Pain Scores [ Time Frame: 2 days ]
    Pain scores by the Visual Analog Scale (VAS) and Wisconsin Brief Pain Inventory (BPI), collected once the day of surgery (at least 2 hours post-op), and both the morning and afternoon/evening on post-operative day #1.

Enrollment: 75
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivicaine
TAP block with bupivicaine/epinephrine placed prior to surgery.
Drug: Bupivicaine
The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis
Placebo Comparator: Placebo
TAP block with placebo placed prior to surgery
Drug: Placebo
The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC.
  • Patients must be ≥18 years old.
  • Patients must be English speaking.
  • Patients must have the ability to understand visual and verbal pain scales.
  • ASA physical status 1-3.

Exclusion Criteria:

  • Known allergy to local anesthetics.
  • Immunocompromised.
  • Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up.
  • Known history of chronic pain disorders.
  • Pregnancy or lactation.
  • Patient is a prisoner or incarcerated.
  • Significant liver disease that would inhibit prescription of opioids.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01444924

United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: David M Kushner, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT01444924     History of Changes
Other Study ID Numbers: 2011-0274
CO11701 ( Other Identifier: UWCCC )
Study First Received: September 29, 2011
Results First Received: June 6, 2014
Last Updated: July 18, 2016

Keywords provided by University of Wisconsin, Madison:
Pain control
Gynecologic Oncology

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on June 22, 2017