Status:
UNKNOWN
The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting
Lead Sponsor:
University of Manitoba
Conditions:
Postoperative Pain.
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
We hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass graftin...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients whom are able and willing to provide written informed consent.
- Male and female 18-70 years of age.
- Patients whom are undergoing isolated coronary artery bypass grafting through a midline sternotomy for the treatment of ischemic heart disease.
- Exclusion criteria
- Patients undergoing cardiac surgery for valvular or pericardial surgery.
- Patients with a documented ejection fraction of less than 50%.
- Patients with known chronic renal insufficiency and a calculated creatinine clearance of \< 60mL/min.
- Patients with known sensitivity to the study drugs.
- Patients with documented pre-existing chronic pain.
- Patients with seizure disorders.
- Patients whom are taking pregabalin or gabapentin
- Patients on chronic neuroleptic medications for control of psychiatric disorders as to avoid possible drug interactions and to avoid modulation of any pain states by such medications.
- Patients whom are taking tricyclic antidepressants or serotonin and norepinephrine re-uptake inhibitors(SNRI) will be excluded because of the effect of these drugs on neuropathic pain.
- Patients greater than 70 years of age will also be excluded because of their increased risk of side-effects and perioperative confusion.
- Pregnant or breast feeding females
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00623285
Start Date
April 1 2008
End Date
June 1 2011
Last Update
March 16 2011
Active Locations (1)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6