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Clinical Trials/NCT01444924
NCT01444924
Completed
Phase 2

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial

University of Wisconsin, Madison1 site in 1 country75 target enrollmentSeptember 2011

Overview

Phase
Phase 2
Intervention
Bupivicaine
Conditions
Gynecologic Cancer
Sponsor
University of Wisconsin, Madison
Enrollment
75
Locations
1
Primary Endpoint
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
March 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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.

Arms & Interventions

Bupivicaine

TAP block with bupivicaine/epinephrine placed prior to surgery.

Intervention: Bupivicaine

Placebo

TAP block with placebo placed prior to surgery

Intervention: Placebo

Outcomes

Primary Outcomes

24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents

Time Frame: 24 hours

Secondary Outcomes

  • Pain Scores(from 2 hours post-op to the afternoon/evening of post-op day #1)

Study Sites (1)

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