Clinical trial NCT01555073
Conditions: Uterine Fibroids Uterine Artery Embolization
Sponsor: Northwestern University
Start date: 2011-10-01; Completion date: 2013-10-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

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.

Detailed description:

Arms: arm 1: pregabalin/celecoxib twice a day for 13 days. arm 2: pregabalin/placebo twice a day for 13 days. arm 3: celecoxib/placebo twice a day for 13 days. arm 4: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Interventions: intervention 1: pregabalin/celecoxib intervention 2: pregabalin/placebo intervention 3: celecoxib/placebo intervention 4: Placebo group
Intervention descriptions: intervention 1: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days. intervention 2: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days. intervention 3: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days. intervention 4: Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Protocol documents: