The purpose of this study is the comparative study of single dose amitriptyline versus pregabalin on postoperative pain reduction after spinal surgery patients. In this randomized, double blind clinical trial, a number of seventy-two patients, twenty to sixty years old, Inclusion criteria: candidate for elective spinal surgery; lack of severe systemic and mental disease; consent to participate in the study and exclusion criteria: history of drug allergy; opiate use; sedative use enrolled in the study. They are randomly divided into three groups: placebo and amitriptyline and Pregabalin. . Thirty min before induction of anesthesia the control group received placebo orally second group takes 25 milligrams amitriptyline and third group 300 milligrams Pregabalin. at the end of surgery after transferring to the ward, one, four and six hours after surgery pain measure and record by collaborator who does not know about grouping by using the Visual Analogue Scale and statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406151617N9
Registration date:2015-10-04, 1394/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-04, 1394/07/12
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of of single dose amitriptiline versus pregabalin on postoperative pain reduction in patients after spinal surgery
Public title
comparision of single dose amitriptiline versus pregabalin on postoperative pain reduction after spinal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for elective spinal surgery; lack of severe systemic and mental disease; consent to participate in the study
Exclusion criteria: history of drug allergy; opiate use; sedative use
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ethic Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
23312
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.1
ICD-10 code description
Radiculopathy
Primary outcomes
1
Description
pain
Timepoint
0,1,4,6 hours after surgery
Method of measurement
Visual analogue score
Secondary outcomes
empty
Intervention groups
1
Description
amitriptyline 25 mg oral tablet with a glass of water 30 minutes before induction of anesthesia
Category
Prevention
2
Description
Pregabalin 300 mg oral tablet with a glass of water 30 minutes before induction of anesthesia
Category
Prevention
3
Description
Placebo oral tablet with a glass of water 30 minutes before induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Hosein Karim
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Tayebeh Khademi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Phone
+98 63 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)