Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)

University of Mississippi Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Conditions

Postoperative Pain Postoperative Nausea and Vomiting

Interventions

RopivacaineDRUG

PlaceboOTHER

Transversus Abdominis Plane BlockPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Mississippi Medical Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

Milligrams of Diludid Consumption During First 48 hours Following Surgery

The amount of diludid received per participant will be recorded from participant medication record at the specified time frame.

Time frame: 48 hours postoperatively

Secondary Outcomes

Level of Nerve (Dermatome) Block

The investigator will complete dermatomal assessments at the specified time frames by using a stimulus in the area of the transversus abdominis plane block to determine the effectiveness of the block.

Time frame: 4hrs postoperative and on postoperative day 1

Pain Scores at Rest and with Movement

Pain severity will be measured using a validated Numerical Rating Scale with 0cm=no pain and 10cm=worst pain imaginable.

Time frame: 2, 4, 6, 12, 24, 36 and 48 hours postoperatively.

Postoperative Nausea and Vomiting

Nausea will be measured using a validated postoperative nausea and vomiting scale known as the Impact Scale.

Time frame: 2, 4, 6, 12, 24, 36 and 48 hours postoperatively.

Data from ClinicalTrials.gov

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