Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abdominal Wall Block Study (TAPB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03074240
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Obesity Procedure: TAPB Group Procedure: RSB Group Procedure: conversion to general anesthesia Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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 Name: 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: 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

Procedure: conversion to general anesthesia
For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.
Other Name: general anesthetic




Primary Outcome Measures :
  1. Changes between the two groups to provide surgical anesthesia [ Time Frame: Changes from baseline (pre-op) to 1 hour post-operative ]
    Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia


Secondary Outcome Measures :
  1. Changes between the two groups assessed by post-operative pain control [ Time Frame: Changes from baseline (post-operative) to 48 hours post-operative ]
    Assessed by instances of numerical rating scale pain scores (0-10)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074240


Contacts
Layout table for location contacts
Contact: Amy M. Gunnett, RN, CCRC 352-273-8911 agunnett@anest.ufl.edu

Locations
Layout table for location information
United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: José R Soberón, MD    352-548-6000    jose.soberon@va.gov   
Sponsors and Collaborators
University of Florida
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: José R Soberón, MD Malcom Randall VA Medical Center

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03074240     History of Changes
Other Study ID Numbers: IRB201602387 - V
OCR18951 ( Other Identifier: University of Florida )
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by University of Florida:
Truncal block
Surgical anesthesia
Postoperative pain control

Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia, Umbilical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Anesthetics
Anesthetics, Local
Anesthetics, General
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents