Objectives: comparing squatting position versus traditional sitting position on ease of spinal needle insertion for induction of spinal anesthesia.
Design: Randomized clinical trial.
Setting: university hospital operating room.
Participants including major eligibility criteria: 222 adults, ASA physical status I and II aged 18-75 who were scheduled for elective surgeries under spinal anesthesia. Major exclusion criteria: language barrier ; contraindications to neuroaxial block ; morbid obesity (BMI> 40) ; pregnancy ; lumbar surgical scar and obvious lumbar scoliosis.
Interventions: patients were instructed about their position according to the allocation in which in squatting group the patient hug his/her knees and sit on the operating table versus traditional sitting positions in which patient sit on the side of the operating table and feet rest on a chair.The anesthesiologist who performs the block, count the number of needle bone contact(0-5) and ease of finding inter vertebral space as easy, difficult, impossible that was recorded in the questionnaire by resident of anesthesiology.
Main outcome measures: The primary outcome was the number of needle-bone contacts and secondary outcome was ease of space identification/needle insertion. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208215264N4
Registration date:2013-02-19, 1391/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-19, 1391/12/01
Registrant information
Name
Sussan Soltani Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 5296
Email address
soltanmo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor research,Tehran university of medical sciences
Expected recruitment start date
2010-01-10, 1388/10/20
Expected recruitment end date
2012-01-03, 1390/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the squatting position versus traditional sitting position for ease of spinal needle placement; a randomized clinical trial
Public title
Comparing the squatting with sitting position for spinal anesthesia
Purpose
Other
Inclusion/Exclusion criteria
Major eligibility criteria: patients with ASA class I or II aged 18-75 who were scheduled for lower abdominal or lower extremity surgeries under spinal anesthesia
Major exclusion criteria: language barrier ; contraindications to neuroaxial block ; morbid obesity (BMI> 40) ; pregnancy ; lumbar surgical scar and obvious lumbar scoliosis.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
222
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of research institue,Tehran University of Medical Sciences
Street address
Keshavraz blv,Poorsina street,North of Tehran university ,Faculty of medicine
City
Tehran
Postal code
1417613151
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
89/d/220/22366
Health conditions studied
1
Description of health condition studied
Operations on lower abdominal or lower limbs under spinal anesthesia including general surgeries,obstetric and gynecologic surgeries and orthopedic surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of bone contact
Timepoint
Once at the time of block
Method of measurement
Counting the number of bone contact
Secondary outcomes
1
Description
Ease of space identification/needle insertion
Timepoint
Once at the time of block performance
Method of measurement
Easy or difficult or impossible
Intervention groups
1
Description
Intervention group:squatting position in which patient hug her/his knees while her/his buttocks and feet rest on the operating table
Category
Early detection
2
Description
Control group:traditional sitting position in which patients sit on the side of operating table while her/his feet hang and rest on a chair
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Sussan Soltani Mohammadi
Street address
North Kargar street, Ale-Ahmad highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
Keshavarz blv,Poorsina street
City
Tehran
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,Tehran 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
Tehran university of medical sciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Dr Shariati hospital,North Kargar street, Ale-Ahmad highway
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
Email
soltanmo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
Associate professor
Other areas of specialty/work
Street address
Dr Shariati hospital, North Kargar street,Ale-Ahmad highway
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
Email
soltanmo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Dr Shariati Hospital,North Kargar street,Ale-Ahmad highway
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)