This study was an interventional study. After approval the project, all patients candidate for surgery referred to academic hospitals affiliated to Babol University of Medical Sciences and spinal anesthesia was done for them, considered as the study population. All of the referal patients donot have criteria for arriving to our investigation so ,three hundred patients were recruited in the study by simple randomized method. Those with a contraindication of LP were excluded. Five to 7 mlit/kg crystalloid were prescribed before spinal anesthesia. Anesthesia was done in semisitting position, in L3 to S1 intraspinal space with a size 25 needle (G25). Then patient goes as supine position and after reaching to a sufficient anesthesia level, operation would be started. Dexamethasone 8 miligrams, Midasolam 1-2 miligrams or Fentanyle 1.5-2 micrograms per body weight were used after spinal anesthesia regards to the age and type of surgery. CSF fluid situation, intraspinal space used for spinal anesthesia, type and amount of infused drugs into intratecal space, liquid supplementation and type of surgery were recorded in a checklist. During the spinal anesthesia, vital signs were checked for all and recorded. All patients were followed up to a week after discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203113305N3
Registration date:2012-05-30, 1391/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Ebrahim Alijanpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1228 0013
Email address
dralijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Science
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Frequency of post spinal headache and some of related factors
Public title
Frequency of post spinal headache and some of related factors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidate for surgery referred to academic hospitals affiliated to Babol University of Medical Sciences and accepted to use spinal anesthesia
Exclusion criteria:
Contraindications for LP, psychotic patients or brain space- occupying lesions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University Of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz St
City
Babol
Postal code
Approval date
2012-05-01, 1391/02/12
Ethics committee reference number
6266/30/ژ/پ
Health conditions studied
1
Description of health condition studied
post spinal headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes
Primary outcomes
1
Description
headache
Timepoint
daily
Method of measurement
question & answer(check list)
Secondary outcomes
empty
Intervention groups
1
Description
After the presentation of post spinal headache, signs & symptoms; it will be treated according to the severity by prescription medicine in out or in patients form. For out-patients NSAIDs, Caffeine & Dexamethasone will prescribe. For in-patient's Blood epidural Patch and serum therapy will be done. For example Cap Novafen (300mg Acetaminophen, 200mg Ibuprofen, and 80mg caffeine) will be drug of choice.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
City
Babol
2
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Science
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Science
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
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.comans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue