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Abdominal Wall Block Study (TAPB)

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University of Florida

Status

Completed

Conditions

Umbilical Hernia
Obesity

Treatments

Procedure: RSB Group
Procedure: TAPB Group
Procedure: conversion to general anesthesia

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03074240
OCR18951 (Other Identifier)
IRB201602387 - V

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

TAPB Group
Active Comparator group
Description:
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.
Treatment:
Procedure: conversion to general anesthesia
Procedure: TAPB Group
RSB Group
Active Comparator group
Description:
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.
Treatment:
Procedure: conversion to general anesthesia
Procedure: RSB Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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