Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by St. Luke's Hospital and Health Network, Pennsylvania.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02233400 record still lists
NCT02233400 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen is the first listed.
NCT02233400 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02233400's enrollment target sits among peer trials
113 723rd of 2000 higher than 1,277 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00748254 · 113 participants
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis
- NCT04753190 · 113 participants · NA
Light Timing Study
- NCT05799248 · 113 participants · Phase 3
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- NCT07216105 · 113 participants · Phase 1
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia