Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)



Status:Withdrawn
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:5/14/2016
Start Date:June 2015
End Date:June 2016

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

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.

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.

Inclusion Criteria:

- Age≥18 years old and not pregnant

- Must be able to provide informed consent - functional understanding of English

- Undergoes exploratory laparotomy with midline abdominal incision

Exclusion Criteria:

- History of substance abuse

- History of chronic pain syndrome

- Daily opioid use for more than 1 month

- Patients considered to have chorioamnionitis at the time of cesarean surgery as
determined by the attending physician

- Prior abdominal surgery involving mesh or placement of an ostomy site as this may
disrupt the plane in which the anesthetic may spread

- Allergy to local anesthetics

- History of cardiac arrhythmias or cardiac abnormalities

- History of seizure disorder

- Liver disease
We found this trial at
1
site
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Mildred Ridgway, MD
Phone: 601-815-7038
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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mi
from
Jackson, MS
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