Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- 24 hour post operative opioid consumption, converted to intravenous morphine equivalents [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Pain scores [ Time Frame: 2 days ] [ Designated as safety issue: No ]Pain scores by the Visual Analog Scale (VAS) and Wisconsin Brief Pain Inventory (BPI), collected once the day of surgery (at least 2 hours post-op), and both the morning and afternoon/evening on post-operative day #1.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Cancer Connectemail@example.com|
|Contact: Sarah Stewartfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 email@example.com|
|Contact: Sarah Stewart 608-263-0796 firstname.lastname@example.org|
|Principal Investigator: David M Kushner, MD|
|Principal Investigator:||David M Kushner, MD||University of Wisconsin, Madison|