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Preemptive Analgesia Following Uterine Artery Embolization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555073
Recruitment Status : Terminated (Subjects did not meet inclusion criteria)
First Posted : March 15, 2012
Results First Posted : September 18, 2014
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Uterine Artery Embolization Drug: pregabalin/celecoxib Drug: pregabalin/placebo Drug: celecoxib/placebo Drug: Placebo group Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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:
  • Celebrex
  • Lyrica

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

Primary Outcome Measures :
  1. Post Operative Pain Control [ Time Frame: Expected average of 12 weeks ]
    To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Expected average of 12 weeks ]
    To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555073

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Responsible Party: Antoun Nader, Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University Identifier: NCT01555073    
Other Study ID Numbers: STU00004604
First Posted: March 15, 2012    Key Record Dates
Results First Posted: September 18, 2014
Last Update Posted: July 28, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors