Obesity, Umbilical Hernia
Conditions
Keywords
Truncal block, Surgical anesthesia, Postoperative pain control
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.
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.
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.
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.
PROCEDUREconversion to general anesthesia
For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.
Sponsors
US Department of Veterans Affairs
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes between the two groups to provide surgical anesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes between the two groups assessed by post-operative pain control | Changes from baseline (post-operative) to 48 hours post-operative | Assessed by instances of numerical rating scale pain scores (0-10) |
Countries
United States
Outcome results
None listed