Preemptive Analgesia Following Uterine Artery Embolization

NCT ID: NCT01555073

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Uterine Fibroids; Uterine Artery Embolization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin/celecoxib group

pregabalin/celecoxib twice a day for 13 days.

Group Type: ACTIVE_COMPARATOR

pregabalin/celecoxib

Intervention Type: DRUG

pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.

Pregabalin/placebo group

pregabalin/placebo twice a day for 13 days.

Group Type: ACTIVE_COMPARATOR

pregabalin/placebo

Intervention Type: DRUG

pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.

Celecoxib/placebo group

celecoxib/placebo twice a day for 13 days.

Group Type: ACTIVE_COMPARATOR

celecoxib/placebo

Intervention Type: DRUG

celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.

Placebo group

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DRUG

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Interventions

pregabalin/celecoxib

pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.

Intervention Type: DRUG

pregabalin/placebo

pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.

Intervention Type: DRUG

celecoxib/placebo

celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.

Intervention Type: DRUG

Placebo group

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Intervention Type: DRUG

Other Intervention Names

Celebrex; Lyrica; Lyrica; Celebrex; Placebo

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Antoun Nader

Professor in Anesthesiology and Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00004604

Identifier Type: -

Identifier Source: org_study_id