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

Postoperative Pain. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00623285
• Other study ID #: PG2007
• Secondary ID: AOC
• Status: Recruiting
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: March 14, 2011
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: University of Manitoba
• Contact: Joel A Loiselle, MD
• Phone: 204-237-2580
• Email: jloiselle[@]sbgh.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain.

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores and morphine consumption post surgery		6 months	No
Secondary	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	Yes