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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 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 23 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01555073
The ClinicalTrials.gov registry entry for NCT01555073 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo group is the first listed.
NCT01555073 reports 0 study locations.
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.
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