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CompletedNCT03074240TAPBUpdated May 30, 2024

Abdominal Wall Block Study

An interventional study of TAPB Group and RSB Group in Umbilical Hernia and Obesity, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Umbilical Hernia
  • Obesity

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Keywords

  • Truncal block
  • Surgical anesthesia
  • Postoperative pain control
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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 · Procedure: conversion to general anesthesia

  • 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: RSB Group · Procedure: conversion to general anesthesia

Interventions

  • ProcedureTAPB 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.

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

  • ProcedureRSB 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.

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

  • Procedureconversion to general anesthesia

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

    Also known as: general anesthetic

05

What researchers measure

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

    Time frame: Changes from baseline (pre-op) to 1 hour post-operative

Secondary outcomes

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

    Assessed by instances of numerical rating scale pain scores (0-10)

    Time frame: Changes from baseline (post-operative) to 48 hours post-operative

06

Study locations

1 site
  • Malcom Randall VA Medical Center
    Gainesville, Florida 32608, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03074240
Lead sponsor
University of Florida
Collaborators
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 8, 2017
Start date
Aug 7, 2017
Primary completion
Jul 12, 2021
Completion
Jul 12, 2021
Last update
May 30, 2024

Study contacts

José R Soberón, MD
principal investigator · Malcom Randall VA Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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