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NCT Number: NCT01444924

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

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.

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Key information

Conditions

Gynecologic Cancer Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bupivicaine

Drug

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

Drug

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 outcomes

  1. 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents

    Time frame: 24 hours

Secondary outcomes

  1. Pain Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 3, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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