Preemptive Analgesia Following Uterine Artery Embolization

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Fibroids, Uterine Artery Embolization

Intervention / Treatment
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* Drug: pregabalin/celecoxib
* Drug: pregabalin/placebo
* Drug: celecoxib/placebo
* Drug: Placebo group


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin/celecoxib group<br>pregabalin/celecoxib twice a day for 13 days. | Drug: pregabalin/celecoxib<br>* pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.<br>* Other names: Lyrica;|
| Active Comparator: Pregabalin/placebo group<br>pregabalin/placebo twice a day for 13 days. | Drug: pregabalin/placebo<br>* pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.<br>* Other names: Lyrica;|
| Active Comparator: Celecoxib/placebo group<br>celecoxib/placebo twice a day for 13 days. | Drug: celecoxib/placebo<br>* celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.<br>* Other names: Celebrex;|
| Placebo Comparator: Placebo group<br>Placebo group, two placebo tablets day of surgery and twice a day for 13 days | Drug: Placebo group<br>* Placebo group, two placebo tablets day of surgery and twice a day for 13 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Control | To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure. | Expected average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods. | Expected average of 12 weeks |