A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
Public ClinicalTrials.gov record NCT02233400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: A Double-Blind Prospective Randomized Trial in A Single Accredited Bariatric Center
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02233400
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 113 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2013
- Primary completion
- Dec 31, 2013
- Completion
- Jun 30, 2014
- Last update posted
- Sep 7, 2014
2013 – 2014
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St Luke's University Hospital | Allentown | Pennsylvania | 18104 | — |
| St Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02233400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 7, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02233400 live on ClinicalTrials.gov.