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

October 14, 2011
September 11, 2014
October 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01555073 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Preemptive Analgesia Following Uterine Artery Embolization
A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uterine Fibroids
  • Uterine Artery Embolization
  • Drug: pregabalin/celecoxib
    pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
    Other Names:
    • Celebrex
    • Lyrica
  • Drug: pregabalin/placebo
    pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
    Other Name: Lyrica
  • Drug: celecoxib/placebo
    celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
    Other Name: Celebrex
  • Drug: Placebo group
    Placebo group, two placebo tablets day of surgery and twice a day for 13 days
    Other Name: Placebo
  • Active Comparator: Pregabalin/celecoxib group
    pregabalin/celecoxib twice a day for 13 days.
    Intervention: Drug: pregabalin/celecoxib
  • Active Comparator: Pregabalin/placebo group
    pregabalin/placebo twice a day for 13 days.
    Intervention: Drug: pregabalin/placebo
  • Active Comparator: Celecoxib/placebo group
    celecoxib/placebo twice a day for 13 days.
    Intervention: Drug: celecoxib/placebo
  • Placebo Comparator: Placebo group
    Placebo group, two placebo tablets day of surgery and twice a day for 13 days
    Intervention: Drug: Placebo group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
October 2013
August 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01555073
STU00004604
No
Antoun Nader, Northwestern University
Northwestern University
Not Provided
Not Provided
Northwestern University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP