Request for Funding
Medical Student Research Fellowship for Summer 2011

All descriptions must contain enough detail to permit an assessment of the problem that is to be addressed and the methodologies that are to be employed. Please be careful to outline the role that the student will play in the project that is described. Please ensure that all relevant approval numbers (IRB, IACUC) are provided.

Mentor:           Babatunde Ogunnaike, MD
Department:   Anesthesiology and Pain Management    
Room number: PMH 2nd Floor, MC 9068
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, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)

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 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. 

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:

Summer Research Students in 2008 and 2009 – Abstracts presented.