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Terminated Phase 4 Interventional Results available

Preemptive Analgesia Following Uterine Artery Embolization

ClinicalTrials.gov ID: NCT01555073

Public ClinicalTrials.gov record NCT01555073. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 together with epidural analgesia may improve pain management as well as having an effect on long term sequelae.

Study identification

NCT ID
NCT01555073
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Northwestern University
Other
Enrollment
23 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2011
Primary completion
Jul 31, 2013
Completion
Sep 30, 2013
Last update posted
Jul 27, 2016

2011 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Northwestern Memorial Hospital Chicago Illinois 60611

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01555073, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 27, 2016 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01555073 live on ClinicalTrials.gov.

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