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NCT06658574 · ClinicalTrials.gov registry record · Phase 2
Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients
A Phase 2 study of Bariatric Surgery and Post Operative Analgesia, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06658574: Recruiting Phase 2 study of Bariatric Surgery and Post Operative Analgesia, sponsored by Rutgers, The State University of New Jersey.
NCT06658574 is a Phase 2 study of Bariatric Surgery and Post Operative Analgesia that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 150 participants, above the 89-participant average among 15 other Bariatric Surgery trials with a reported enrollment target (69% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06658574, a Phase 2 study of Bariatric Surgery and Post Operative Analgesia, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.
Primary Outcome
Numeric Pain Score (The scale has a fixed range with 0 representing "no pain" and the upper limit of 10 representing "worst pain possible"). A single numeric pain score is shown as an average of multiple combined time points.
Conditions Studied
Interventions
- DRUG Acetaminophen
Study Locations (1)
New Jersey
- Robert Wood Johnson University Hospital - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT06658574 shows while recruiting
NCT06658574 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 15 other Bariatric Surgery trials with a reported enrollment target (69% higher).
The record links to 5 conditions, with Bariatric Surgery appearing as the primary indexed condition, and to 1 intervention - of which Acetaminophen is the first listed.
NCT06658574 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06658574 about?
NCT06658574 is a clinical study titled "Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients". Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any ...
What is the current status of trial NCT06658574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-11-13. Estimated completion is 2026-05.
What conditions does trial NCT06658574 study?
This clinical trial studies the following conditions: Bariatric Surgery, Post Operative Analgesia, Bariatric Surgery Patients, Bariatric Surgery (Gastric Bypass), Perioperative Analgesia.
What interventions are being tested in trial NCT06658574?
The interventions under investigation include: Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT06658574?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06658574 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06658574's enrollment target sits among peer trials
150 4th of 15 higher than 12 of 15 other Bariatric Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bariatric Surgery 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.
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