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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00623285
First received: February 14, 2008
Last updated: March 14, 2011
Last verified: March 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

Resource links provided by NLM:


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: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 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.
Other Name: Lyrica
Placebo Comparator: Group 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Jill Leake 204-258-1328 jleake@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: Angie Munoz, RN    204-237-2793    amunoz@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: Joel Loiselle, MD, FRCPC, St. Boniface General Hospital/University of Manitoba
ClinicalTrials.gov Identifier: NCT00623285     History of Changes
Other Study ID Numbers: PG2007, AOC
Study First Received: February 14, 2008
Last Updated: March 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Pain.
Postoperative.
CABG.

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014