Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Post-operative Pain
• Intervention / Treatment: Drug: Bupivicaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from 2 hours post-op to the afternoon/evening of post-op day #1

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (ESTIMATE): October 3, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Surgery; Pain control; Gynecologic Oncology
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2011-0274 (OTHER: Institutional Review Board); A532820 (Other Identifier: UW Madison); CO11701 (OTHER: UWCCC); SMPH\OBSTET & GYNECOL ONC (OTHER: UW Madison); NCI-2011-03675 (REGISTRY: NCI Trial ID)