Preemptive Analgesia Following Uterine Artery Embolization
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Fibroids Uterine Artery Embolization |
Drug: pregabalin/celecoxib Drug: pregabalin/placebo Drug: celecoxib/placebo Drug: Placebo group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization |
- post operative pain control [ Time Frame: Expected average of 12 weeks ] [ Designated as safety issue: No ]To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
- Quality of life [ Time Frame: Expected average of 12 weeks ] [ Designated as safety issue: No ]To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pregabalin/celecoxib group
pregabalin/celecoxib twice a day for 13 days.
|
Drug: pregabalin/celecoxib
pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
Other Names:
|
|
Active Comparator: Pregabalin/placebo group
pregabalin/placebo twice a day for 13 days.
|
Drug: pregabalin/placebo
pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
Other Name: Lyrica
|
|
Active Comparator: Celecoxib/placebo group
celecoxib/placebo twice a day for 13 days.
|
Drug: celecoxib/placebo
celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
Other Name: Celebrex
|
|
Placebo Comparator: Placebo group
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
|
Drug: Placebo group
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Antoun Nader, M.D. | 312-926-5278 | anader2@northwestern.edu |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Antoun Nader, M.D. 312-926-5278 anader2@northwestern.edu | |
| Sub-Investigator: Mark Kendall, M.D. | |
More Information
No publications provided
| Responsible Party: | Antoun Nader, Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01555073 History of Changes |
| Other Study ID Numbers: | STU00004604 |
| Study First Received: | October 14, 2011 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anticonvulsants Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Pregabalin Celecoxib Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013