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NCT04263909 · ClinicalTrials.gov registry record · Phase 4
The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 199
- Enrollment target
NCT04263909: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT04263909 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 199 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263909, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 199 participants
- Enrollment target
Study Summary
In this study the investigators plan to examine the perioperative use of sufentanil sublingual (SL) in the analgesic regimen for spine surgery, one of the most common surgeries performed in the US. Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. Currently, no data are available for this patient population which routinely experiences moderate to severe acute pain. The investigators will analyze whether sufentanil SL is associated with lower opioid consumption in the post anesthesia care unit and pain scores.
Primary Outcome
pain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain)
Interventions
- DRUG Sublingual Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 4 |
What the finished NCT04263909 record still lists
NCT04263909 is an interventional study that assigns participants to a tested intervention. The registered 199 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 (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Sublingual Tablet is the first listed.
NCT04263909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04263909 about?
NCT04263909 is a clinical study titled "The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients". In this study the investigators plan to examine the perioperative use of sufentanil sublingual (SL) in the analgesic regimen for spine surgery, one of the most common surgeries performed in the US. Patients undergoing spinal fusion surgery often experience severe pain during the first three postoper...
What is the current status of trial NCT04263909?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 199 participants. The study started on 2020-12-01. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT04263909?
The interventions under investigation include: Sublingual Tablet (DRUG).
Who is sponsoring clinical trial NCT04263909?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04263909's enrollment target sits among peer trials
199 445th of 2000 higher than 1,555 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
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