The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

Study Overview
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Brief Summary
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We hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass grafting, and reduces the incidence of opioid-induced side effects such as respiratory depression. This may reduce ICU admission and possibly abbreviate length of hospital stay.

Official Title
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The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

Conditions
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Postoperative Pain.

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo/Lactose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: Pregabalin<br>* Pregabalin 150mg orally 60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive 150mg twice a day through the first 2 post-operative days for a total of six doses.<br>* Other names: Lyrica;|
| Placebo Comparator: Group 2<br> | Drug: Placebo/Lactose<br>* Matching Placebo orally,60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive placebo twice a day through the first 2 post-operative days for a total of six doses. If the patient is unable to swallow and NG tube is in place, the medication can be dissolved in water and administered through the NG tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores and morphine consumption post surgery |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the occurrence of opioid-related side effects such as nausea, vomiting, and respiratory depression in patients receiving pregabalin compared to those receiving placebo. |  | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain., Postoperative., CABG.