Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: lyrica
Intervention description: 150mg of pregabalin/placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pregabalin; Postoperative pain; Mastectomy

Summary:

      This study will compare the effects of oral pregabalin with placebo on postoperative pain and
      morphine usage after mastectomy.

      Pregabalin is an anticonvulsant agent approved by the United States Food and Drug
      Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic
      neuralgia and diabetic neuropathy.

      Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with
      axillary node dissection will be recruited to participate in the study. Patients unable to
      cooperative, those that have known allergy to pregabalin or morphine and a history of drug or
      alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired
      kidney function will all be excluded from the study. A pregnancy test will also be performed
      to exclude pregnant women from the study.

      Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery
      followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be
      administered twice daily until day 14. Whether a patient receives pregabalin or placebo will
      be decided based on a process similar to tossing a coin.

      Patients will receive a standard general anesthetic for their operation and will receive
      intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate
      postoperative period. Oral opioids will be administered after discontinuation of the PCA.

      Subjects will be visited after the operation while in the hospital and intermittently for
      three months at the outpatient clinic after discharge from the hospital. Subjects will be
      asked to return remaining study drug/empty container when they are at the hospital for their
      2 week follow up visit.

      Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema,
      weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side
      effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all
      patients for the occurrence of these side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women, 18-70 years of age

          2. ASA physical status I to III

          3. Undergoing unilateral modified radical mastectomy or lumpectomy with axillary node
             dissection

        Exclusion Criteria:

          1. Patients unable to cooperate

          2. Have known allergy to pregabalin or morphine

          3. A history of drug or alcohol abuse

          4. History of chronic pain

          5. Daily intake of analgesics or steroids

          6. Impaired kidney function