Recruiting
Phase 3

Pregabalin

Sponsor:

University of Manitoba

Code:

NCT00623285

Conditions

Postoperative Pain.

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Pregabalin

Placebo/Lactose

Study Details

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 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.

Conditions

Postoperative Pain.

Study ID

NCT00623285

Start date

Apr, 2008

Status verified date

Mar, 2011

Completion date

Jun, 2011

Anticipated

Primary completion date

Mar, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

placebo comparator: Group 2

Interventions

Pregabalin

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.

Placebo/Lactose

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.

Primary outcome measure

  • Pain scores and morphine consumption post surgery [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Joel A Loiselle, MD

204-237-2580jloiselle@sbgh.mb.ca

Jill Leake

204-258-1328jleake@sbgh.mb.ca

Locations

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Joel A Loiselle, MD

204-237-2580jloiselle@sbgh.mb.ca

Angie Munoz, RN

204-237-2793amunoz@sbgh.mb.ca

Principal Investigator:

Joel A Loieselle, MD

More Information

Sponsor

University of Manitoba

Last update posted

Mar 16, 2011

Last verified

Mar, 2011

Keywords

  • Pain.
  • Postoperative.
  • CABG.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2011-03-16.