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Completed

NCT Number: NCT03074240

Abdominal Wall Block Study

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, Transversus abdominis plane blocks

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.

Other names: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, rectus sheath blocks

conversion to general anesthesia

Procedure

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

Other names: general anesthetic

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study 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.

Acronym: TAPB

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2017
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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