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

Information source: University of Manitoba
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain.

Intervention: Pregabalin (Drug); Placebo/Lactose (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Joel A Loieselle, MD, Principal Investigator, Affiliation: St. Boniface General Hospital and U of M

Overall contact:
Joel A Loiselle, MD, Phone: 204-237-2580, Email: jloiselle@sbgh.mb.ca

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.

Clinical Details

Official title: The Effects of Peri-Operative Pregabalin Administration on Post-Operative Analgesia in Patients Undergoing Coronary Bypass Grafting

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Pain scores and morphine consumption post surgery

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

- Patients whom are able to operate a PCA machine.

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

Locations and Contacts

Joel A Loiselle, MD, Phone: 204-237-2580, Email: jloiselle@sbgh.mb.ca

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada; Recruiting
Joel A Loiselle, MD, Phone: 204-237-2580, Email: jloiselle@sbgh.mb.ca
Rachel Gerstein, RN, Phone: 204-237-2793, Email: rgerstein@sbgh.mb.ca
Joel A Loieselle, MD, Principal Investigator
Ricky Singh, MD, Sub-Investigator
Additional Information

Starting date: April 2008
Ending date: March 2009
Last updated: August 26, 2008

Page last updated: February 12, 2009

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