Abdominal Wall Block Study

Obesity Clinical Trial

— TAPB  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074240
• Other study ID #: IRB201602387 - V
• Secondary ID: OCR18951
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: July 12, 2021

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Umbilical
• Obesity
• Umbilical Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes between the two groups assessed by post-operative pain control	Assessed by instances of numerical rating scale pain scores (0-10)	Changes from baseline (post-operative) to 48 hours post-operative