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

Primary Purpose

Postoperative Pain.

Status

Unknown status

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Pregabalin

Placebo/Lactose

About this trial

This is an interventional treatment trial for Postoperative Pain. focused on measuring Pain., Postoperative., CABG.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Boniface General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Pain scores and morphine consumption post surgery

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.

Full Information

NCT ID

NCT00623285

First Posted

February 14, 2008

Last Updated

March 14, 2011

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT00623285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

March 2011 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Manitoba

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain.

Keywords

Pain., Postoperative., CABG.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Title

Group 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo/Lactose

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain scores and morphine consumption post surgery

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joel A Loiselle, MD

Phone

204-237-2580

jloiselle@sbgh.mb.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Jill Leake

Phone

204-258-1328

jleake@sbgh.mb.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel A Loieselle, MD

Organizational Affiliation

St. Boniface General Hospital and U of M

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Boniface General Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joel A Loiselle, MD

Phone

204-237-2580

jloiselle@sbgh.mb.ca

First Name & Middle Initial & Last Name & Degree

Angie Munoz, RN

Phone

204-237-2793

amunoz@sbgh.mb.ca

First Name & Middle Initial & Last Name & Degree

Joel A Loieselle, MD

First Name & Middle Initial & Last Name & Degree

Ricky Singh, MD

12. IPD Sharing Statement

Learn more about this trial

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

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