Abdominal Wall Block Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective and Randomized Comparison of Ultrasound-guided Transversus Abdominis Plane Versus Rectus Sheath Blocks as a Primary Anesthetic for Abdominal Wall Surgery in Adults.

Conditions
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Umbilical Hernia, Obesity

Intervention / Treatment
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* Procedure: TAPB Group
* Procedure: RSB Group
* Procedure: conversion to general anesthesia


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAPB Group<br>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. | Procedure: TAPB Group<br>* Subjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.<br>* Other names: Transversus abdominis plane blocks;Procedure: conversion to general anesthesia<br>* For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.<br>* Other names: general anesthetic;|
| Active Comparator: RSB Group<br>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. | Procedure: RSB Group<br>* Subjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.<br>* Other names: rectus sheath blocks;Procedure: conversion to general anesthesia<br>* For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.<br>* Other names: general anesthetic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Truncal block, Surgical anesthesia, Postoperative pain control