Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
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|ClinicalTrials.gov Identifier: NCT01444924|
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : September 23, 2014
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Cancer Post-operative Pain||Drug: Bupivicaine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
TAP block with bupivicaine/epinephrine placed prior to surgery.
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 Comparator: Placebo
TAP block with placebo placed prior to surgery
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.
- 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents [ Time Frame: 24 hours ]
- Pain Scores [ Time Frame: from 2 hours post-op to the afternoon/evening of post-op day #1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444924
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||David M Kushner, MD||University of Wisconsin, Madison|