In this randomized,double blind trial we will investigate the effect of intravenous hydrocortison in post dural puncture headache after spinal anesthesia.80 patients men or women between 20 to 60 ages candidated for lower abdominal surgery will be recruited and randomly assigned into two groups(intervention/control)inclusion criteria is surgery with spinal anaesthesia and exclusion criteria are patient incontinency,coagulation disorders and other contraindication.For patient in intervention group,hydrocortison 200mg and for patients in control group, 4cc normal sali. will be administered intravenous 15 minutes before spinal anesthesia.Probable headache intensity will be measured at the baseline,12 hour,24 hour,48 hour and 1 week after intervention.The other complications will be assesed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504067313N3
Registration date:2015-05-22, 1394/03/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-22, 1394/03/01
Registrant information
Name
Mirmohammadtaghi Mortazavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 1953
Email address
mortazavimt@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chanceller for research- Tabriz University of Medical Sciences
Expected recruitment start date
2015-06-11, 1394/03/21
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Prophylactic Hydrocortisone in Post Dural Puncture Headache after Spinal Anesthesia
Public title
Effects of Prophylactic Hydrocortisone in Post Dural Puncture Headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:lower abdomen surgery(ASA l-ll); age 15-60; indication for spinal anesthesia
exclusion criteria:chronic consumption of analgesic; ASA lll-Vl; history of addiction and psychologic disorders; migrane
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee،Tabriz university of medical sciences
Street address
daneshgah avenue,tabriz medical university,medicine college
City
tabriz
Postal code
Approval date
2014-04-28, 1393/02/08
Ethics committee reference number
9325
Health conditions studied
1
Description of health condition studied
postdural puncture headache
ICD-10 code
O74.5
ICD-10 code description
spinal and epidural anaesthesia-induced headache during labour and delivery
2
Description of health condition studied
postdural puncture headache
ICD-10 code
T88.5
ICD-10 code description
other complications of anasthesia
Primary outcomes
1
Description
headache intensity
Timepoint
recovery,12,24,48 and one week after surgery
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Amp hydrocortison 200mg will be administerd bolus over 30 seconds intravenous 15 minutes before spinal anesthesia
Category
Treatment - Drugs
2
Description
4cc normal salin 15minute before spinal anesthesia will be administered intravenous.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.M.Mortazavi
Street address
Tabriz University of Medical Sciences, Golgasht Avn, Kuye daneshga, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chanceller for research - Tabriz University of Medical Sciences
Full name of responsible person
mirmohammadtaghi mortazavi
Street address
Tabriz University of Medical sciences, Kuye daneshga avenue, Tabriz, eastern azarbayjan
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chanceller for research - Tabriz 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
Tabriz University of Medical sciences
Full name of responsible person
Rahim Dargahi
Position
Medical Intern
Other areas of specialty/work
Street address
Tabriz University of Medical sciences,kuye daneshga avenue,tabriz
City
Tabriz
Postal code
Phone
+98 41 3669 1953
Fax
Email
mortazavimmt@yahoo.com;mortazavimt@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
medical university of tabriz
Full name of responsible person
mirmohamad taghi mortazavi
Position
anesthesia attendent
Other areas of specialty/work
Street address
elgoli highway,golshahr,shohada hospital
City
tabriz
Postal code
Phone
+98 41 3669 1953
Fax
Email
mortazavimmt@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shohada Hospital
Full name of responsible person
dr.mortazavi
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Tabriz
Postal code
51678846171
Phone
+98 41 3443 2150
Fax
Email
mortazavimt@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)