Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

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. Identifier: NCT01444924
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : September 23, 2014
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Gynecologic Cancer Post-operative Pain Drug: Bupivicaine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: from 2 hours post-op to the afternoon/evening of post-op day #1 ]
    Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

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 identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison Identifier: NCT01444924     History of Changes
Other Study ID Numbers: 2011-0274
CO11701 ( Other Identifier: UWCCC )
First Posted: October 3, 2011    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: April 5, 2018
Last Verified: March 2018

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