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

University of Manitoba

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain.

Treatments: Drug: Placebo/Lactose; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00623285

PG2007

AOC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Treatment:

Drug: Pregabalin

Group 2

Placebo Comparator group

Treatment:

Drug: Placebo/Lactose