Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444924
• Other study ID #: 2011-0274
• Secondary ID: CO117012011-0274
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Cancer
• Pain, Postoperative
• Post-operative Pain

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents		24 hours
Secondary	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

External Links

•   University of Wisconsin Carbone Cancer Center