Preemptive Analgesia Following Uterine Artery Embolization
Condition: Uterine Fibroids; Uterine Artery Embolization
MeSH terms: Leiomyoma
Intervention: pregabalin/celecoxib; pregabalin/placebo; celecoxib/placebo; Placebo group
Intervention description: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.; pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.; celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.; Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Intervention MeSH terms: Celecoxib; Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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.