Status:
COMPLETED
A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
Lead Sponsor:
St. Luke's Hospital and Health Network, Pennsylvania
Conditions:
Hospital Costs
Length of Stay
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Bariatric surgery is the only proven and effective long term treatment for morbid obesity. In an attempt to reduce patients' post-operative hospital stay, lower associated health care costs, and impro...
Detailed Description
This was a double-blind, prospective, randomized controlled trial conducted at a single accredited bariatric center that is part of a multi-campus university teaching hospital. The Institutional Revie...
Eligibility Criteria
Inclusion
- age \> 18
- attendance at an informational seminar and support group
- clearance for surgery by a registered dietician and certified social worker
- BMI \> 35 with at least one co-morbid condition (e.g., hypertension, diabetes mellitus, sleep apnea, hypercholesterolemia) or BMI \> 40 without any co-morbid conditions
- negative pregnancy test
- American Society of Anesthesiology score 1-3
- ability to understand instructions and comply with all study requirements
- preoperative %excess weight loss (%EWL) of 3-10%
- no contraindication for a LRYGB or LSG based on upper endoscopy findings
- preoperative cardiac consultation for risk stratification
- evaluation by a sleep medicine specialist to identify risk factors for sleep apnea, with treatment as deemed appropriate
Exclusion
- revisional surgery
- conversion to open procedure
- chronic musculoskeletal pain
- narcotics or NSAIDs use in the 7 days prior to surgery
- history of fibromyalgia
- sensitivity to acetaminophen or liver disease (i.e., elevated LFT or history of hepatitis or liver failure)
- use of monoamine oxidase inhibitor in the 7 days prior to surgery
- use of any medication containing acetaminophen
- allergy to morphine or oxycodone
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT02233400
Start Date
February 1 2013
End Date
July 1 2014
Last Update
September 8 2014
Active Locations (2)
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1
St Luke's University Hospital
Allentown, Pennsylvania, United States, 18104
2
St Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015