Evaluation of prophylactic effects of intravenous hydrocortisone on incidence and severity of post dural puncture headache after spinal anesthesia in comparison to control group
Post-dural puncture headache was known as an unpleasant complication after spinal anesthesia. Release of inflammatory mediators from puncture site was described as a contributing factor in this headache. Anti-inflammatory drugs such as hydrocortisone can reduce inflammation and release of inflammatory mediators, so this study was designed to evaluate prophylactic effects of hydrocortisone on post-dural puncture headache.
Seventy candidates of lower extremity and/or lower abdominal surgeries under spinal anesthesia allocate in two groups and in a double blind clinical trial take hydrocortisone (5mg/kg) or placebo, intravenously, 20 minutes before spinal anesthesia. Two groups compare for incidence and severity of headache, in first 3 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071216415N4
Registration date:2014-07-17, 1393/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-17, 1393/04/26
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic effects of intravenous hydrocortisone on incidence and severity of post dural puncture headache after spinal anesthesia in comparison to control group
Public title
Evaluation of effects of hydrocortisone on prevention of post spinal headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 15 to 65 years old; ASA 1 and 2; candidates of lower extremity or lower abdominal surgeries under spinal anesthesia; no history of migraine headache; no history of prescription of steroidal or non-steroidal anti-inflammatory drugs; without opiate addiction
Exclusion criteria: Failure of spinal anesthesia
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics comity of vice research of medical school of Isfahan university of medical sciences
Street address
Vice research of medical school, Isfahan University of Medical Sciences, Hezarjarib boulevard; Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
16260
Health conditions studied
1
Description of health condition studied
Post-dural puncture headache
ICD-10 code
Y56.0
ICD-10 code description
Local antifungal, anti-infective and anti-inflammatory drugs, not elsewhere classified
Primary outcomes
1
Description
Headache
Timepoint
2; 6; 12 and 48 hours after surgery
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Nausea and Vomitting
Timepoint
2; 6; 24 and 48 after surgery
Method of measurement
Visual Analog Scale (VAS)
Intervention groups
1
Description
Intervention: Prescription of intravenous hydrocortison 5 mg/kg
Category
Treatment - Drugs
2
Description
Control group: Normal saline as a placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Golparvar M. MD
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and technology of Isfahan University of Medical Sciences
Full name of responsible person
Dr Alimohammad Sabzeghabaei
Street address
Research manager office, Deputy of research and technology; Isfahan University of Medical Sciences; Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and technology of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar M MD
Position
Associate professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Anesthesia, Alzahra Medical center; Sofeh boulvard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center; Sofeh boulevard; Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, St Alzahra Hospital, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)