Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Phase 2

Completed

• Conditions: Gynecologic Cancer; Post-operative Pain
• Interventions: Drug: Bupivicaine; Drug: Placebo

• Registration Number: NCT01444924
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-03
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Results First Submitted: 2014-06-06
• Results First Submitted QC: 2014-09-15
• Results First Posted: 2014-09-23
• Status Verified: 2018-03
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivicaine	Bupivicaine	TAP block with bupivicaine/epinephrine placed prior to surgery.
Placebo	Placebo	TAP block with placebo placed prior to surgery

Primary Outcome Measures

Name	Time	Method
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents	24 hours

Secondary Outcome Measures

Name	Time	Method
Pain Scores	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.

Trial Locations

Locations (1)

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States