View Clinical Trial (Medical Research Study)
A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60611 |
| Conditions: |
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Uterine Fibroids - Uterine Artery Embolization |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Adult female patients (>18 years of age) who are undergoing elective uterine artery
embolization will be included in the study.
Exclusion Criteria:
- Exclusion criteria for the study are patient refusal to be included in the study, the
presence of language barrier that inhibits proper communication with the patient
- Contraindications to regional anesthesia
- History of allergy to amide local anesthetics or narcotics
- Known hypersensitivity to pregabalin, creatinine clearance ≤ 60 mL/min
- The presence of a progressive neurological deficit
- The presence of chronic opioid analgesia
- The presence of a coagulopathy or infection, pregnancy
- Patients with cardiovascular disease
- Patients who take daily antiplatelet medications, patients with peptic ulcer disease
- History of psychiatric disorder or inability to follow study protocol.
- Dropout criteria include failed epidural analgesia, inability to tolerate side
effects (nausea) from pregabalin, and the inability to contact during follow up.
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| NCT ID: |
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NCT01555073 |
| Primary Contact: |
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Antoun Nader, M.D.
Phone: 312-926-5278
Email: anader2@northwestern.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60611
United States
Antoun Nader, M.D.
Phone: 312-926-5278
Email: anader2@northwestern.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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