Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica
Recruitment status was Active, not recruiting
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.
Eighty female patients between 17 and 80 years of age will be recruited to participate in the study. Those with known allergy to pregabalin or morphine and those with a history of alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, and patients with impaired kidney function or diabetes mellitus will be excluded from the study. Blood tests will be performed before surgery to determine if a patient qualifies for enrollment in the study. A pregnancy test will also be performed to exclude pregnant women from the study. About 20 to 30 ml of blood will be collected for the tests.
Either oral pregabalin 300 mg or placebo will be administered to each patient one to two hours before surgery followed by 150 mg or placebo 12 hours later. Thereafter, 150 mg 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy|
- The Effects of Oral Pregabalin on Postoperative Opioid Requirement after Mastectomy [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]IV-PCA morphine for rescue pain management in the immediate postoperative period and oral opioids after discontinuation of IV-PCA
- To evaluate the effects of pregabalin on pain scores after mastectomy [ Time Frame: 90 days ] [ Designated as safety issue: No ]Pain assessments at 7, 14, 30, 60 and 90 days
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: pregabalin
150mg of pregabalin/placebo
Placebo Comparator: placebo
150mg of pregabalin/placebo
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