NCT00623285

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3 postoperative-pain

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

2.9 years

First QC Date

February 14, 2008

Last Update Submit

March 14, 2011

Conditions

Postoperative Pain.

Keywords

Pain.Postoperative.CABG.

Outcome Measures

Primary Outcomes (1)

  • Pain scores and morphine consumption post surgery

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

Group 1

EXPERIMENTAL
Drug: Pregabalin

Group 2

PLACEBO COMPARATOR
Drug: Placebo/Lactose

Interventions

PregabalinDRUG

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.

Also known as: Lyrica
Group 1
Placebo/LactoseDRUG

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.

Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

PregabalinLactose

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Joel A Loieselle, MD

    St. Boniface General Hospital and U of M

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel A Loiselle, MD

CONTACT

204-237-2580jloiselle@sbgh.mb.ca

Jill Leake

CONTACT

204-258-1328jleake@sbgh.mb.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

CA(1)