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Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

This study is currently recruiting participants.
Verified October 2012 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01444924
First received: September 29, 2011
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 68
Study Start Date: September 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444924

Contacts
Contact: Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
Contact: Sarah Stewart 608-263-0796 slstewart@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect     800-622-8922     cancerconnect@uwcarbone.wisc.edu    
Contact: Sarah Stewart     608-263-0796     slstewart@wisc.edu    
Principal Investigator: David M Kushner, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David M Kushner, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01444924     History of Changes
Other Study ID Numbers: 2011-0274, CO11701
Study First Received: September 29, 2011
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 May 21, 2013