Bariatric Surgery Clinical Trial
Official title:
Transverse Abdominal Plane Blocks for Bariatric Surgery Patients: A Single Blinded Randomized Controlled Study
Verified date | November 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 23 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. The patient must be 18 years of age or older and able to provide his or her own consent. 2. The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass. 3. The patient must be surgically and medically accepted for the procedure 4. Good functional status, ability to perform activities of daily living 5. The patients BMI > 35, no upper limit 6. Signed study specific informed consent prior to enrollment Exclusion Criteria: 1. Patients with an allergy to local anesthetics 2. Patients diagnosed with peripheral neuropathies including diabetes mellitus. 3. Patients with BMI <35 4. Patients with significant coronary artery disease 5. Patient refusal of block procedure. 6. Patients with chronic pain 7. Patients on pre-operative maintenance narcotics 8. American Society of Anesthesiologist classification system 4 (ASA 4) patients |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post Operative Opioid Usage | The amounts of opioids used by the patient will be collected by a person blinded to the allocation group | 24 hour after surgery | |
Secondary | Pain Score Assessed With Visual Analog Score (VAS) | Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU) | 30 minutes within arrival to PACU | |
Secondary | Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review | The number of participants experiencing nausea will be assessed by chart review | Up to 5 hours | |
Secondary | Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | The number of participants experiencing vomiting will be assessed by chart review | Up to 5 hours |
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