Preemptive Analgesia Following Uterine Artery Embolization
Primary Purpose
Uterine Fibroids, Uterine Artery Embolization
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pregabalin/celecoxib
pregabalin/placebo
celecoxib/placebo
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
Eligibility 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.
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Pregabalin/celecoxib group
Pregabalin/placebo group
Celecoxib/placebo group
Placebo group
Arm Description
pregabalin/celecoxib twice a day for 13 days.
pregabalin/placebo twice a day for 13 days.
celecoxib/placebo twice a day for 13 days.
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01555073
First Posted
October 14, 2011
Last Updated
June 29, 2016
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01555073
Brief Title
Preemptive Analgesia Following Uterine Artery Embolization
Official Title
A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Subjects did not meet inclusion criteria
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Uterine Artery Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin/celecoxib group
Arm Type
Active Comparator
Arm Description
pregabalin/celecoxib twice a day for 13 days.
Arm Title
Pregabalin/placebo group
Arm Type
Active Comparator
Arm Description
pregabalin/placebo twice a day for 13 days.
Arm Title
Celecoxib/placebo group
Arm Type
Active Comparator
Arm Description
celecoxib/placebo twice a day for 13 days.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Intervention Type
Drug
Intervention Name(s)
pregabalin/celecoxib
Other Intervention Name(s)
Celebrex, Lyrica
Intervention Description
pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
Intervention Type
Drug
Intervention Name(s)
pregabalin/placebo
Other Intervention Name(s)
Lyrica
Intervention Description
pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
Intervention Type
Drug
Intervention Name(s)
celecoxib/placebo
Other Intervention Name(s)
Celebrex
Intervention Description
celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
Intervention Type
Drug
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Placebo
Intervention Description
Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Primary Outcome Measure Information:
Title
Post Operative Pain Control
Description
To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Time Frame
Expected average of 12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.
Time Frame
Expected average of 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
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Preemptive Analgesia Following Uterine Artery Embolization
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