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
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