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NCT02233400 · ClinicalTrials.gov registry record · Phase 4
A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
A Phase 4 study, sponsored by St. Luke's Hospital and Health Network, Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 113
- Enrollment target
NCT02233400 is a Phase 4 study that has completed, run by St. Luke's Hospital and Health Network, Pennsylvania. The registered enrollment target is 113 participants.
The verdict
NCT02233400, a Phase 4 study, has completed, sponsored by St. Luke's Hospital and Health Network, Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 113 participants
- Enrollment target
Study 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-repea
Interventions
- DRUG Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02233400
The ClinicalTrials.gov registry entry for NCT02233400 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Luke's Hospital and Health Network, Pennsylvania, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen is the first listed.
NCT02233400 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02233400 about?
NCT02233400 is a clinical study titled "A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery". 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 ba...
What is the current status of trial NCT02233400?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 113 participants. The study started on 2013-02. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02233400?
The interventions under investigation include: Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02233400?
This trial is sponsored by St. Luke's Hospital and Health Network, Pennsylvania, which has 8 total clinical trials registered on ClinicalTrials.gov.
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