Comparing the incidence of post dural puncture headache following spinal anesthesia in sitting and lateral decubitous position in patients under caesarian section
Objective:
Comparing the incidence of post dural puncture headache following spinal anesthesia between the sitting and lateral decubitous positioned patients under caesarian section.
Design:
Single blinded randomized controlled trial setting.
Setting and conduct:
-Sitting positioned group: The patients legs are flattened opposite to the body.
-Lateral positioned group: The patient is right lateral decubitus and her knees are fully flexed to the abdomen.
The two groups:
-will receive 300cc ringer lactate before the operation.
-They will be anesthetised by injecting of 2 cc bupivacaine plus 1 cc sufentanyl by a NO: 24 needle midlinely through the l3-l4 space.
-They will quickly be flattened upward after the procedure.
Inclusion criteria;
All elective cesarean candidates
Exclusion criteria;
Chronic and migraine headaches
; Any obstetrics complication
; Chronic use of analgesics
; Spinal anesthesia contraindications
-Primary outcome:
Headache, 24& 72 hours after the operation will be asked from the patients by a blinded person.
Secondary outcomes:
Anesthetic level: will be measured 5 minutes after anesthesia.
Hypotension: The Blood pressure will be measured by non invasive blood pressure every 3 minutes,
And will be treated by ephedrine, while noted.
Nausea & vomiting: will be noted if were seen.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205059644N1
Registration date:2013-02-06, 1391/11/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-06, 1391/11/18
Registrant information
Name
Mohammad reza Ebadian
Name of organization / entity
Hamedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0025
Email address
mr.ebadian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2013-02-10, 1391/11/22
Expected recruitment end date
2013-03-12, 1391/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the incidence of post dural puncture headache following spinal anesthesia in sitting and lateral decubitous position in patients under caesarian section
Public title
The effect of sitting or lateral decubitous position on postdural puncture Headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria;
All elective cesarean candidates
Exclusion criteria;
Chronic and migraine headaches
; Any obstetrics complication
; Chronic use of analgesics
; Spinal anesthesia contraindications
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
The ethic,s commity for the Hamedan university of medical sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamedan
Postal code
65178.518
Approval date
2011-12-17, 1390/09/26
Ethics committee reference number
3209/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
G97.0
ICD-10 code description
Cerebrospinal fluid leak from spinal puncture
Primary outcomes
1
Description
Headache
Timepoint
1st and 3th day after s/a
Method of measurement
pain scored ruler and the number of used analgesic
Secondary outcomes
1
Description
Nausea and Vomitting
Timepoint
Operation time, 1st and 3rd days after spinal anesthesia
Method of measurement
Question from the patients
2
Description
Sensory level
Timepoint
5 minutes after spinal anesthsia
Method of measurement
Stimulation by a needle
3
Description
Hypotension
Timepoint
Every 3 minutes
Method of measurement
Non invasive blood pressure
Intervention groups
1
Description
In the sitting positioned group the patient,s legs are flattend opposite to her face, then the procieduer will be done.
Category
N/A
2
Description
In the lateral postioned group, the patients will lye on right lateral position and keep their khnees flexed to their abdomen, then the prociedure will done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Mohammad Reza Ebadian
Street address
Fatemieh Hospital, Pasdaran Ave
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamadan
Grant name
ندارد
Grant code / Reference number
000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research the Technology, 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
Hamedan university of Medical Sciences
Full name of responsible person
Mohammad Reza Ebadian
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamedan
Postal code
6517838695
Phone
+98 81 1825 2087
Fax
+98 82 52087
Email
mr.ebadian@umsha.ac.ir; mrebadian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan university of Medical Sciences
Full name of responsible person
Maryam Davoudi
Position
Proffesor associated
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamedan
Postal code
6517838695
Phone
00
Fax
Email
mdavudi10@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Ebadian
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamedan
Postal code
6517838695
Phone
+98 811264002051
Fax
+98 81 1264 0016
Email
mrebadian@gmail.com; mr.ebadian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)