A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 4
Details
Lead Sponsor:
St. Luke's Hospital and Health Network, Pennsylvania