The aim of this single blinded simple randomized clinical trial is to evaluate of “reverse flow” technique in prevention of headache after dural puncture in cesarean section under spinal anesthesia which performed in Fatemieh hospital.Single blinded trial means that patients don't know whether they are in intervention or control group. After informed consent patients divided into two groups: intervention and control.In simple random sampling we select patients from a large population.Each individual is chosen by chance and each patient has a equal chance of being included in the sample. Each group contains of 120 patients. In intervention group we mix 3 cc marcaine 0.5 % and 1 cc fentanyl and inject 3 cc of this mixture into subaracnoid space by 24 gauge spinal needle then simultaneously with injection of 1 cc of this mixture ,needle is withdrawn. In control group only 3 cc of this mixture inject into subaracnoid space and we have no injection while needle withdrawing. Then we evaluate PDPH at 6, 12, 18, 24, 48, 72 hours after operation and if patient have PDPH we determine severity of pain with Numerical Rating Scale.
General information
Acronym
PDPH: Post Dural Puncture Headache; ASA: American Society of Anesthesiologists;
IRCT registration information
IRCT registration number:IRCT2015030111822N4
Registration date:2015-10-12, 1394/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Behrooz Karkhanei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
karkhanei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research and Technology, Hamadan University of Medical Science
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of “Reverse flow” technique in prevention of post dural puncture headache in cesarean section under spinal anesthesia
Public title
Evaluation of “Reverse flow” technique in prevention of post dural puncture headache in cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cesarean section; ASA I & II;
Exclusion criteria: patient’s refusal; concomitant another surgery; more than 2 time dural puncture in spinal technique; analgesic usage before operation; history of chronic headache; history of PDPH
Age
From 15 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Medical Sciences
Street address
Hamadan University Of Medical Sciences, Shaheed Famideh Street
City
Hamadan
Postal code
6517838695
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
p/16/35/9/6388
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during the puerperium
Primary outcomes
1
Description
Severity of headache
Timepoint
6 hours after procedure, 12 hours after procedure, 18 hours after procedure, 24 hours after procedure, second day after procedure, third day after procedure
Method of measurement
Numerical Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group we mix 3 cc marcaine 0.5 % and 1 cc fentayl and inject 3 cc of this mixture into subaracnoid space by 24 gauge spinal needle then simultaneously with injection of 1 cc of this mixture ,needle is withdrawn.
Category
Prevention
2
Description
In control group only 3 cc of this mixture inject into subaracnoid space and we have no injection while needle withdrawing.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Marjan Lashgary
Street address
Fatemieh Hospital, pasdaran street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Vice chancellor of Research and Technology , Hamadan University of Medical Sciences, Shaheed Fahmideh Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Hamadan University Of Medical Sciences, Shaheed Famideh Street
City
Hamadan
Postal code
Phone
+98 81 3838 0574
Fax
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Hamadan University Of Medical Sciences, Shaheed Famideh Street
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0574
Fax
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Marjan Lashgary
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7011
Fax
Email
marjan_0084@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)