Patients will be divided to 2 groups; study and placebo after taking the letter of satisfaction for controlling of headache due to surgery. In study group a DOCA ampule 5mg/cc will be injected a quarter before spinal anesthesia. The questioner person who is a medicine student isn't aware of DOCA injection. In placebo group normal saline 1 cc will be injected. At the end, per 24 hours during one week existence of headache and its severity will be measured by VAS. For parametric variables with normal distribution curve "independent T test" or "unpaired T test" and for parametric data with abnormal distribution "mann whithney"and for qualitative variables chi square tests " and also about frequent measurements "repeated measures dependent variable test" will be used. Data will be studied by SPSS15 statistic software. P<0.05 will be sensitive statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014113016956N3
Registration date:2015-05-26, 1394/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-26, 1394/03/05
Registrant information
Name
Hassan Mohammadipour Anvari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dr.anvari22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz medicine university
Expected recruitment start date
2015-05-18, 1394/02/28
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic single dose of Desoxy corticosterone acetate on post dural puncture headache after spinal anesthesia.
Public title
Effect of Desoxy corticosterone acetate on post dural puncture headache after spinal anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all 18-60 years old patients candidate for elective general surgery by spinal anesthesia; ASA I-II.
Exclusion criteria: the history of migraine headache; the history of backache; history of hypertension; history of spinal anesthesia or lumbar puncture in the recent month; history of lumbar puncture more than 2 times; history of high ICP; psychopathic condition; other instances for forbidding spinal anesthesia such as local infection and coagulopathy disorders; the use of Digoxin and diuretics.
Age
From 17 years old to 59 years old
Gender
Both
Phase
N/A
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Postal code
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
92236
Health conditions studied
1
Description of health condition studied
The Post dural puncture Headache after spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Headache severity
Timepoint
Per 24 hours during one week
Method of measurement
By VAS
Secondary outcomes
1
Description
oedema
Timepoint
daily
Method of measurement
questionnaire
2
Description
vomiting & nausea
Timepoint
Daily
Method of measurement
Graded questionnaire
3
Description
diarrhea
Timepoint
daily
Method of measurement
questionnaire
Intervention groups
1
Description
In study group:a DOCA ampul 5mg/cc will be injected a quarter before spinal anesthesia.
Category
Prevention
2
Description
In control group:normal saline 1cc will be injected.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Hassan Mohammadipour Anvari
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Dr Hasan Mohhamadipoor Anvari
Street address
School of Medicine, Tabriz University of Medical Sceinces
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sceinces
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
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Mohhamadipoor Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
dr.anvari22@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Mohammahipoor Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emamreza hospitol
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
dr.anvari22@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Mohammadipour Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospital
City
Tabriz
Postal code
Phone
Fax
Email
dr.anvari22@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)