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NCT01555073 · ClinicalTrials.gov registry record · Phase 4
Preemptive Analgesia Following Uterine Artery Embolization
A Phase 4 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT01555073: Clinical Trial Phase 4 study, sponsored by Northwestern University.
NCT01555073 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555073, a Phase 4 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique called uterine artery embolization has become increasingly popular due to high patient satisfaction, cost effectiveness, and shorter recovery period. The purpose of this randomized blinded placebo controlled study is to compare pre-emptive analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term pain control, and improved quality of life in woman following uterine artery embolization surgery. The study consists of four drug groups including a placebo group. The addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as leading to a better post-procedure outcome in women following uterine artery embolization. Many investigators believe that the ischemia in the normal myometrium is the primary source of pain immediately following surgery making postoperative pain management challenging. Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to being an effective analgesic for chronic pain syndromes, the use of pregabalin provides effective postoperative analgesia when it is administered pre-emptively before an operation. Preemptive analgesia involves the introduction of an analgesic regimen before the onset of noxious stimuli, with the goal of preventing sensitization of the nervous system to subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and celecoxib togethe
Primary Outcome
To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Interventions
- DRUG Placebo group
- DRUG pregabalin/celecoxib
- DRUG pregabalin/placebo
- DRUG celecoxib/placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
Why NCT01555073 stopped before completion
NCT01555073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo group is the first listed.
NCT01555073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555073 about?
NCT01555073 is a clinical study titled "Preemptive Analgesia Following Uterine Artery Embolization". Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique ca...
What is the current status of trial NCT01555073?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2011-10. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01555073?
The interventions under investigation include: Placebo group (DRUG), pregabalin/celecoxib (DRUG), pregabalin/placebo (DRUG), celecoxib/placebo (DRUG).
Who is sponsoring clinical trial NCT01555073?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01555073's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 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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