Abdominal Wall Block Study

University of Florida15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Umbilical Hernia Obesity

Interventions

TAPB GroupPROCEDURE

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 GroupPROCEDURE

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 anesthesiaPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Malcom Randall VA Medical Center

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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