Abdominal Wall Block Study

NCT03074240 | Completed

• 2 other identifiers: IRB201602387 - VOCR18951
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Umbilical Hernia; Obesity

Keywords

Truncal block; Surgical anesthesia; Postoperative pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes between the two groups assessed by post-operative pain control

  Changes from baseline (post-operative) to 48 hours post-operative

Study Arms (2)

TAPB Group

ACTIVE COMPARATOR

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; Procedure: conversion to general anesthesia

RSB Group

ACTIVE COMPARATOR

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; Procedure: conversion to general anesthesia

Interventions

TAPB Group PROCEDURE

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.

Also known as: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, Transversus abdominis plane blocks

TAPB Group

RSB Group PROCEDURE

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.

Also known as: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, rectus sheath blocks

RSB Group

conversion to general anesthesia PROCEDURE

For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.

Also known as: general anesthetic

RSB Group; TAPB Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Hernia, Umbilical; Obesity

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• José R Soberón, MD

  Malcom Randall VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: August 7, 2017
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)