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

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00623285

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain.	Drug: Pregabalin Drug: Placebo/Lactose	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Peri-Operative Pregabalin Administration on Post-Operative Analgesia in Patients Undergoing Coronary Bypass Grafting

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Depression Nausea and Vomiting

Drug Information available for: Lactose Pregabalin

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

Pain scores and morphine consumption post surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental	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.
Group 2: Placebo Comparator	Drug: 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.

Arms

Assigned Interventions

Group 1: Experimental

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.

Group 2: Placebo Comparator

Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623285

Contacts

Contact: Joel A Loiselle, MD	204-237-2580	jloiselle@sbgh.mb.ca
Contact: Rachel Gerstein, RN	204-237-2793	rgerstein@sbgh.mb.ca

Locations

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

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator:

Joel A Loieselle, MD

St. Boniface General Hospital and U of M

More Information

No publications provided

Responsible Party:	St. Boniface General Hospital/University of Manitoba ( Joel Loiselle, MD, FRCPC )
Study ID Numbers:	PG2007, AOC
Study First Received:	February 14, 2008
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00623285 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

Pain.
Postoperative.
CABG.

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pregabalin
Pain

Peripheral Nervous System Agents
Analgesics
Anticonvulsants
Pain, Postoperative

Additional relevant MeSH terms:

Physiological Effects of Drugs
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Pain, Postoperative

ClinicalTrials.gov processed this record on September 03, 2009