Preemptive Analgesia Following Uterine Artery Embolization

June 29, 2016 updated by: Antoun Nader, Northwestern University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

March 13, 2012

First Posted (ESTIMATE)

March 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00004604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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