Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)

Postoperative Pain Clinical Trial

— GYNTAP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02506855
• Other study ID #: 2014-0238
• Status: Withdrawn
• Phase: Phase 3
• First received: June 11, 2015
• Last updated: May 12, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• Ropivacaine

Other:
• Placebo

Procedure:
• Transversus Abdominis Plane Block

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours postoperatively	No
Secondary	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.	4hrs postoperative and on postoperative day 1	No
Secondary	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.	2, 4, 6, 12, 24, 36 and 48 hours postoperatively.	No
Secondary	Postoperative Nausea and Vomiting	Nausea will be measured using a validated postoperative nausea and vomiting scale known as the Impact Scale.	2, 4, 6, 12, 24, 36 and 48 hours postoperatively.	No