Headache is one of the side effects of spinal anesthesia that can be cause by leakage of CSF from tip of the needle . The other side effects are backache, nausea, vomiting, tinnitus, hypotension and bradycardia. Size of puncture can effect on leakage of CSF, so the type of needle can influence on severity of side effects. In this double blind randomize trial 162 ASA physical status Ι or ΙΙ patients scheduled for lower limb or lower abdominal segment operation under spinal anesthesia will be chosen. Patients will be randomly divided in two equal groups. Spinal anesthesia will be performed by either a 24-gauge Sprotte needle or a 24-gauge Quincke needle in median method. We will monitor blood pressure and pulse rate of patients up to 30 minutes after anesthesia. Then, up to 24 hour after that, every 4 hour, we will check patient’s symptoms and fill checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009292080N4
Registration date:2010-12-28, 1389/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-28, 1389/10/07
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sprotte and Quincke needles with respect to post dural puncture headache
Public title
Comparison of Sprotte and Quincke needles with respect to post dural puncture headache
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age 16- 65, patients with major surgery of lower limb or lower abdominal segment under spinal anesthesia. Exclusion criteria: patients with chronic headache and drug induced headache.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Postal code
Approval date
2010-02-08, 1388/11/19
Ethics committee reference number
88-70-2
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes
Primary outcomes
1
Description
headache
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist and physical exam
Secondary outcomes
1
Description
tinnitus
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist & physical exam
2
Description
hypotension
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist & physical exam
3
Description
vertigo
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist & physical exam
4
Description
nausea & vomitting
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist & physical exam
5
Description
nuchal rigidity
Timepoint
every 4 hours till 24 hours after surgery
Method of measurement
checklist & physical exam
Intervention groups
1
Description
Sprotte spinal needle
Category
Treatment - Devices
2
Description
Quincke spinal needle
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Dr. Afsane Norouzi
Street address
Valie asr hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Changiz Ashtiyani
Street address
Alamol hoda street
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Afsane Norouzi
Position
Assistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valie asr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsane Norouzi
Position
Assistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valie asar hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
+98 918 161 1365
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ladan Tofangsazi
Position
medical student
Other areas of specialty/work
Street address
Valie asr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
+98 86122247900
Email
ladan_tsazi@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)