Background and aims : The purpose of this study is evaluating of analgesic effect of preemptive gabapentin on postoperative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial in 60 males candidate for coronary bypass surgery. Patients were grouped as gabapentin (n=30) and control group (n=30). Gabapentin group received 800 mg orally two hours before surgery and 400 mg two hours post extubation. Control group received placebo with same period. Outcome: amount of pain according to 11-point numerical scale and cumulative morphine consumption and the incidence of side effects and hemodynamic changes at 2, 6, 12, 18, 24 hours Post extubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103065990N1
Registration date:2011-05-14, 1390/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-14, 1390/02/24
Registrant information
Name
Aminolah Vasigh
Name of organization / entity
Ahwaz Jundishapour university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3477
Email address
vasigh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2009-06-11, 1388/03/21
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Gabapentin effects on morphine consumption and pain after adult heart surgery
Public title
ٍEvaluating analgesic effect of Gabapentin on postoperative pain and morphine consumption after cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men aged 20-70 years undergoing coronary artery bypass graft surgery. Exclusion criteria: history of chronic analgesic use (nonsteroidal anti-inflammatory drugs, opioids, or paracetamol); tranquilizer, anticonvulsant, or antidepressant use; alcohol dependence; malabsorption; hepatic and renal insufficiency; emergency surgery; previous cardiac surgery; left ventricular dysfunction (ejection fraction <40%); preoperative use of inotropic agents or intraaortic balloon pump; and allergy to the study drugs. Patients undergoing redo sternotomy were also excluded from the study.
Age
From 20 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishapour university of medical sciences
Street address
Shaher daneshgah
City
Ahvaz
Postal code
6135715794
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
2629/20/8/پ
Health conditions studied
1
Description of health condition studied
pain relief after CABG surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
morphine consumpsion
Timepoint
2, 6, 12, 24 hours post extubation
Method of measurement
medical records
Secondary outcomes
1
Description
pain
Timepoint
2, 6, 12, 18 hours after extubation
Method of measurement
clinical evaluation (NRS)
Intervention groups
1
Description
Intervention group received 800 mg orally two hours before surgery and 400 mg two hours post extubation.
Category
Prevention
2
Description
control group received placebo with same period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hospital
Full name of responsible person
Dr. Mansour Sultanzadeh
Street address
Azadegan St.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
129006
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mehdi Dehghani Firouzabadi
Position
assistant professor
Other areas of specialty/work
Street address
Cardiac operation room, Imam Khomeini hospital
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1222 2114
Fax
+98 61 1336 1544
Email
mdfiroozabadi834@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Pipelzadeh
Position
associate professor
Other areas of specialty/work
Street address
Imam khomini Hospital, Azadegan St.
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 2114
Email
dr_rpipel@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Aminolah Vasigh
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Imam khomini hospital, Azadegan St.
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1336 1544
Email
dr_amin_vasigh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)