Medical Student Research Fellowship for Summer 2012
Mentor: Babatunde Ogunnaike, MD
Department: Anesthesiology & Pain Management
Room number: PMH 2nd Floor
Mail Code: 9068
Phone number: 214-590-8536
E-mail: babatunde.ogunnaike@utsouthwestern.edu
Project title: Effects Of Oral Pregabalin Versus Placebo On Postoperative Pain And Morphine Consumption After Mastectomy
Human subjects IRB approved project number (where applicable): STU-102010-086
Animal subjects IRB approved project number (where applicable):
Project Type: Patient-based Research
Brief Description of Project.
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 will be excluded from the study. 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.
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.
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.
Previous Research Activities or Publications with Medical Students: