NCT02506855

Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)

Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP): Modifying an Existing Technique for Ease of Administration and Increased Accuracy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study attempts to learn about the effectiveness of a modification to the Transversus Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the abdominal wall postoperatively using ultrasound guidance. The investigators want to see if regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread in the appropriate plane could reduce error and improve postoperative recovery.

Detailed description

This study is a prospective, randomized blinded study that investigates the efficacy of a transversus abdominis plane block under direct view. In this pilot study involving gynecologic patients undergoing open (abdominal wall incision either vertically or horizontally) hysterectomy or other related gynecologic surgery, the investigators will use ropivacaine versus saline for the placebo control group, which in both groups involves injection of agent directly into the appropriate fascial layers prior to abdominal wall closure. Efficacy is to be assessed via measurement of pain scores, nausea and vomiting, and opioid consumption in both participant groups. The number of dermatomes which are blocked in both participant groups during the first 24 hours following surgery will be recorded.

Conditions

• Postoperative Pain
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Ropivacaine
OTHER	Placebo
PROCEDURE	Transversus Abdominis Plane Block

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-07-23
• Last updated: 2016-05-13

Locations

1 site across 1 country: United States