Preemptive Analgesia Following Uterine Artery Embolization

This study has been terminated.
(Subjects did not meet inclusion criteria)
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01555073
First received: October 14, 2011
Last updated: September 11, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 23
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: August 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:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555073

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Antoun Nader, 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
Results First Received: September 11, 2014
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Celecoxib
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticonvulsants
Antirheumatic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014