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Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

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ClinicalTrials.gov Identifier: NCT01444924
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : September 23, 2014
Last Update Posted : July 20, 2016
Sponsor:
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
Primary Completion Date : February 2013
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: 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT01444924


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov 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: July 20, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents