Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Gynecologic Cancer, Post-operative Pain

Intervention / Treatment
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* Drug: Bupivicaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine<br>TAP block with bupivicaine/epinephrine placed prior to surgery. | Drug: Bupivicaine<br>* 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<br>|
| Placebo Comparator: Placebo<br>TAP block with placebo placed prior to surgery | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Pain control, Gynecologic Oncology