Abdominal Wall Block Study (TAPB)

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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Umbilical Hernia
• Intervention / Treatment: Procedure: TAPB Group; Procedure: conversion to general anesthesia; Procedure: RSB Group

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: TAPB Group; 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.; Other Names: truncal peripheral nerve blocks; anesthetize the abdominal wall; ultrasound-guided regional anesthesia; Transversus abdominis plane blocks; Procedure: conversion to general anesthesia; For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.; Other Names: general anesthetic
Active Comparator: 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.	Procedure: conversion to general anesthesia; For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.; Other Names: general anesthetic; Procedure: RSB Group; 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.; Other Names: truncal peripheral nerve blocks; anesthetize the abdominal wall; ultrasound-guided regional anesthesia; rectus sheath blocks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: José R Soberón, MD, Malcom Randall VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Truncal block; Surgical anesthesia; Postoperative pain control
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, General
• Other Study ID Numbers: IRB201602387 - V; OCR18951 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No