Phase 2
N=64
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
Gynecologic Cancer · Post-operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01444924 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents — 64.9; 69.3 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bupivicaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents |
64.9; 69.3 | — |
| SECONDARY Pain Scores |
3.12; 3.61; 6.44; 6.97 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01444924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.