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Phase 2 Completed N=64 Randomized Quadruple-blind Supportive Care

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Cancer · Post-operative Pain
Source: ClinicalTrials.gov NCT01444924 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents — 64.9; 69.3 mg

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.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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