NCT01444924
Completed
Phase 2
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Bupivicaine
- Conditions
- Gynecologic Cancer
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Bupivicaine
TAP block with bupivicaine/epinephrine placed prior to surgery.
Intervention: Bupivicaine
Placebo
TAP block with placebo placed prior to surgery
Intervention: Placebo
Outcomes
Primary Outcomes
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
Time Frame: 24 hours
Secondary Outcomes
- Pain Scores(from 2 hours post-op to the afternoon/evening of post-op day #1)
Study Sites (1)
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