Comparison of median and paramedian approaches to spinal anesthesia in terms of the incidence of headache and backache, and the regression of spinal sensory level in patients undergoing elective cesarean section
This study aims to compare median and paramedian approaches to spinal anesthesia in terms of the incidence of headache and backache, and the regression of spinal sensory level. The population includes all patients undergoing elective cesarean section, and the sample includes 138 women aged 18-45 who meet the inclusion criteria to the study. The inclusion criteria includes patients in ASA I and II classes and indication of spinal anesthesia; the exclusion criteria includes patients with a history of preoperative chronic headache and backache, and the puncture of the dura mater more than one time.
The study is of a single-blind design. First, the patients will be divided in the operating room into two groups of 69 persons using the table of random numbers. One group will be given median, and the other the paramedian spinal anesthesia (0.7 to 1 mg/kg of %5 lidocaine). Then, the patients will be assessed in terms of headache and backache, and the regression of spinal sensory level by someone unaware of spinal approach, first in the recovery room, and 48 hours later in the ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101711147N1
Registration date:2013-11-11, 1392/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-11, 1392/08/20
Registrant information
Name
Tahere Khazaei
Name of organization / entity
University of Medical Sciences Birjand
Country
Iran (Islamic Republic of)
Phone
+98 56 1431 4657
Email address
azar1342@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of median and paramedian approaches to spinal anesthesia in terms of the incidence of headache and backache, and the regression of spinal sensory level in patients undergoing elective cesarean section
Public title
Effects of two spinal anesthesia approaches in the incidence of headache, backache, and regression of sensory level after operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- All patients in ASA I and II classes aged 18-45,
2- indication of spinal anesthesia (lack of peripheral neuropathy, needle insertion site infection, coagulopathy)
Exclusion criteria:
1- patients of above ASA I and II classes
2- Chronic back pain and headache
3- General anesthesia concurrent with spinal
4- puncture of the dura mater more than one time
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
138
Randomization (investigator's opinion)
N/A
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 Commitee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
9717853577
Approval date
2012-10-06, 1391/07/15
Ethics committee reference number
79677/125
Health conditions studied
1
Description of health condition studied
elective caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
backache
Timepoint
in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours
Method of measurement
The visual analogue scale (VAS) standard questionnaire will be used to measure backache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.
2
Description
headache
Timepoint
in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours
Method of measurement
The visual analogue scale (VAS) standard questionnaire will be used to measure headache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.
Secondary outcomes
1
Description
regression of sensory level
Timepoint
10 minutes to 2 hours after surgery in the recovery room
Method of measurement
sensation of coldness and light touch by alcohol
Intervention groups
1
Description
In the first group, a 23- gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg /Kg is injected into the subarachnoid space for spinal anesthesia with median approach (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted from superior boarder of spinous process of inferior vertebra in the midline of the selected space).
Category
Prevention
2
Description
In the second group, a 23-gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg/Kg is injected into the subarachnoid space (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted 1 cm external and 0.5 cm inferior into the selected space with 20 degrees toward the L4-L5 vertebra).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mahmoud Ganji
Street address
Anesthesia Group, Operating Room, Valiasr Hospital, Ghaffari Street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences, Vice Chancellery for Research and Information Technology
Full name of responsible person
Asghar Zarban
Street address
Vice Chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences, Vice Chancellery for Research and Information Technology
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
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Position
Director of Research Affairs
Other areas of specialty/work
Street address
Vice Chancellery of Research and Information Technology, Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
9717853577
Phone
+98 56 1443 1183
Fax
+98 56 1444 9011
Email
rezamood@yahoo.com
Web page address
www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Shima Sheibani
Position
Anesthesiologist
Other areas of specialty/work
Street address
No 3, Niloofar St., Sajjad Blvd
City
Mashad
Postal code
Phone
+98 51 1764 7230
Fax
Email
shimasheibany@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Position
Director of Research Affairs
Other areas of specialty/work
Street address
Vice Chancellery of Research and Information Technology, Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
9717853577
Phone
+98 56 1443 1183
Fax
+98 56 1444 9011
Email
rezamood@yahoo.com
Web page address
www.bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)