Abdominal Wall Block Study

Not Applicable

Completed

• Conditions: Umbilical Hernia; Obesity
• Interventions: Procedure: RSB Group; Procedure: TAPB Group; Procedure: conversion to general anesthesia

• Registration Number: NCT03074240
• Lead Sponsor: University of Florida

Brief Summary

Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.

Detailed Description

The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Study Start: 2017-08-07
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients ≥ 18 years of age undergoing umbilical hernia repair
• Overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively)
• Ability to understand and provide informed consent

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Exclusion Criteria

• Patient refusal or inability to provide informed consent
• True allergy, not sensitivity, local anesthetics
• True allergy, not sensitivity, Propofol
• True allergy, not sensitivity, general anesthetic agents
• Pregnancy
• Severe hepatic impairment
• Evidence of infection at or near the proposed needle insertion site
• Any sensorimotor deficit, whether acute or chronic, as determined by the PI
• Chronic use of opioid medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSB Group	RSB Group	Compare the instance in the RSB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing RSB to anesthetize the abdominal wall.
RSB Group	conversion to general anesthesia	Compare the instance in the RSB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing RSB to anesthetize the abdominal wall.
TAPB Group	TAPB Group	Compare the instance in the TAPB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing TAPB to anesthetize the abdominal wall.
TAPB Group	conversion to general anesthesia	Compare the instance in the TAPB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing TAPB to anesthetize the abdominal wall.

Primary Outcome Measures

Name	Time	Method
Changes between the two groups to provide surgical anesthesia	Changes from baseline (pre-op) to 1 hour post-operative	Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia

Secondary Outcome Measures

Name	Time	Method
Changes between the two groups assessed by post-operative pain control	Changes from baseline (post-operative) to 48 hours post-operative	Assessed by instances of numerical rating scale pain scores (0-10)

Trial Locations

Locations (1)

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States