A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
Completed · Phase 4
Conditions studied: Hospital Costs, Length of Stay, Postoperative Pain Score, Patient Satisfaction
In brief
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 improve satisfaction scores, St Luke's University Health Network (SLUHN) recently adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is safe and effective when performed in a Center of Excellence (COE) such as ours. However, post-operative pain control remains a challenging issue, with only intravenous (IV) or PO (by mouth) narcotics appropriate for bariatric surgery patients. IV acetaminophen, which has been used successfully in Europe, was recently approved by the Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the use of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its cost effectiveness. Therefore, our study will investigate the economic impact of administering IV acetaminophen to bariatric surgery patients, as well as its effect on clinical outcomes such as patients' post-operative length of stay, self-reported pain, readmissions, emergency room (ER) visits and complications. The study design will be a randomized, double-blind, parallel-group, controlled trial in a single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery candidates \> 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB) or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for the first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data analysis will include quantile regression, mixed randomized-repeated analysis of covariance (ANCOVA) and selected univariate comparisons, with p \< .05 denoting statistical significance for all outcomes.
Key facts
- Study ID
- NCT02233400
- Run by
- St. Luke's Hospital and Health Network, Pennsylvania
- People needed
- 113
- Starts
- 2013-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2014-09-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St Luke's University Hospital — Allentown, Pennsylvania, United States
- St Luke's University Health Network — Bethlehem, Pennsylvania, United States
Full record on ClinicalTrials.gov
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