The aim of this study was evaluation the effect of Dexamethasone on postoperative pain in patients with lumbar discectomy.
Patients for elective lumbar discectomy in a one space were enrolled into the study based on inclusion and exclusion criteria.
Eighty patients in two case and control group evaluated. Time of study was first 24 hour after operation and effects of Dexamethasone on reduce of pain after discectomy evaluated.
Pain state of patients evaluated in post operation with Visual Aualoge Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205279878N1
Registration date:2012-07-03, 1391/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-03, 1391/04/13
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effects of Dexamethasone on postoperative pain after lumber discectomy : Randomized and Double blind study
Public title
Lumber discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred to Lumber discectomy
Exclusion criteria:
Diabetic;Other contraindication of Dexamethasone ; Long-term use of corticosteroids
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz
City
Tabriz
Postal code
Approval date
2012-05-31, 1391/03/11
Ethics committee reference number
5/4/2421
Health conditions studied
1
Description of health condition studied
Low back pain due to Lumbar discopathy
ICD-10 code
M51.2+
ICD-10 code description
Lumbago due to displacement of intervertebral disc
Primary outcomes
1
Description
Pain score
Timepoint
6 , 12 , 18 and 24 houre after surgery
Method of measurement
Based on Visual Aualoge Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group :
Ampule Dexamethasone(8 mg) Single dose after surgery + Ampule Morphine 0.1 mg/kg
Category
Treatment - Drugs
2
Description
Control group:
Ampule Morphine 0.1 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Neurosurgery Ward of Shohada hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Meshkini
Street address
Vice Chancellor for Research , Faculty of Medicine , Gholghasht Street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?