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Preemptive Analgesia Following Uterine Artery Embolization

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Fibroids; Uterine Artery Embolization

Intervention: pregabalin/celecoxib (Drug); pregabalin/placebo (Drug); celecoxib/placebo (Drug); Placebo group (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Northwestern University

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Post Operative Pain Control

Secondary outcome: Quality of Life

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States
Additional Information

Starting date: October 2011
Last updated: September 11, 2014

Page last updated: August 20, 2015

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