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Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Primary Purpose

Gynecologic Cancer, Post-operative Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivicaine
Placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Pain control, Gynecologic Oncology, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivicaine

Placebo

Arm Description

TAP block with bupivicaine/epinephrine placed prior to surgery.

TAP block with placebo placed prior to surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Scores
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.

Full Information

First Posted
September 29, 2011
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01444924
Brief Title
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
Official Title
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Post-operative Pain
Keywords
Pain control, Gynecologic Oncology, Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivicaine
Arm Type
Experimental
Arm Description
TAP block with bupivicaine/epinephrine placed prior to surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TAP block with placebo placed prior to surgery
Intervention Type
Drug
Intervention Name(s)
Bupivicaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Scores
Description
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.
Time Frame
from 2 hours post-op to the afternoon/evening of post-op day #1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kushner, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

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