Phase 2
N=23
Regional TAP Block for Bariatric Patients
Bariatric Surgery · Transverse Abdominal Plane Regional Blocks
Bottom Line
View on ClinicalTrials.gov: NCT04051684 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Post Operative Opioid Usage — 2.25; 4 morphine equivalent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transverse abdominal plane block (Procedure); Ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Opioid Usage |
2.25; 4 | — |
| SECONDARY Pain Score Assessed With Visual Analog Score (VAS) |
5.5; 2 | — |
| SECONDARY Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review |
5; 3 | — |
| SECONDARY Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review |
0; 2 | — |
Summary
Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI >35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room
Eligibility Criteria
Inclusion Criteria
- The patient must be 18 years of age or older and able to provide his or her own consent.
- The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
- The patient must be surgically and medically accepted for the procedure
- Good functional status, ability to perform activities of daily living
- The patients BMI > 35, no upper limit
- Signed study specific informed consent prior to enrollment
Exclusion Criteria
- Patients with an allergy to local anesthetics
- Patients diagnosed with peripheral neuropathies including diabetes mellitus.
- Patients with BMI <35
- Patients with significant coronary artery disease
- Patient refusal of block procedure.
- Patients with chronic pain
- Patients on pre-operative maintenance narcotics
- American Society of Anesthesiologist classification system 4 (ASA 4) patients
Data sourced from ClinicalTrials.gov (NCT04051684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.