The aim of this study was to evaluate the effect of using a squatting position to facilitate spinal block in patients undergoing cesarean section.
Design
Clinical trial, randomized, double blinded with parallel groups on 120 patients
Settings and conduct
The present study was performed in Al-Zahra Hospital in Tabriz. The study is a double-blind study in which the study data was performed by a student and a respected midwife expert who was unaware of the study. Spinal block and patients were monitored by an anesthesiologist and an anesthesia resident.
Participants/Inclusion and exclusion criteria
Patients with ASA class one or two, single-term pregnancy, body mass index below 35 kg/m2, and candidate for elective cesarean section are included in the study. Patients with conscious reluctance to enter the study, candidate for emergency cesarean section, history of spinal surgery or spinal deformity including scoliosis, kyphosis and lordosis, and contraindications to spinal anesthesia are excluded from the study.
Intervention groups
Intervention group: In a squatting position, spinal anesthesia with Quinke needle No. 25 from the inter-vertebral space L2-3 or L3-4 in the midline approach with bupivacaine 0.5% and fentanyl 20 micrograms (total volume of solution 2.2 ml) was done.
Control group: In a classic sitting position, spinal anesthesia with Quinke needle No. 25 from the inter-vertebral space L2-3 or L3-4 in the midline approach with bupivacaine 0.5% and fentanyl 20 micrograms (total volume of solution 2.2 ml) was done.
Main outcome variables
Spinal needle redirection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110712007013N28
Registration date:2020-11-07, 1399/08/17
Registration timing:retrospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Use of squatting position for facilitating of spinal block performance in patients undergoing cesarean
Public title
Squatting for facilitating of spinal block performance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I or II
Single term pregnancy
Body mass index under 35 kg/m2
Candidate for elective cesarean section
Exclusion criteria:
Conscious dissatisfaction to enter the study
Candidate for emergency cesarean section
History of spinal surgery or spinal deformity including scoliosis, kyphosis and lordosis
Contraindications to spinal anesthesia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be using sealed envelopes, of which 120 envelopes will be selected in total and will be divided into two groups of 60, including groups A and B. Envelopes will be selected by the operating room nurse who is blind to the study groups. Group A will be the intervention group, group B will be the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study data were performed by a student and a respected midwife specialist unaware of the study. Spinal block and patients were monitored by an anesthesiologist and an anesthesia resident.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice chancellor for research, Tabriz University of Medicalُ Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.TBZMED.REC.1397.1007
Health conditions studied
1
Description of health condition studied
Facilitating of Spinal Block Performance
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
Spinal needle redirection
Timepoint
When doing spinal block
Method of measurement
Number of spinal needle redirection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In a squatting position, spinal anesthesia with Quinke needle No. 25 from the inter-vertebral space L2-3 or L3-4 in the midline approach with bupivacaine 0.5% and fentanyl 20 micrograms (total volume of solution 2.2 ml ) was done.
Category
Treatment - Other
2
Description
Control group: In a classic sitting position, spinal anesthesia with Quinke needle No. 25 from the inter-vertebral space L2-3 or L3-4 in the midline approach with bupivacaine 0.5% and fentanyl 20 micrograms (total volume of solution 2.2 ml ) was done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation Room and Cesarean setting, Al Zahra Hospital,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Operating room, Dr. Simin Atashkhoyi
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3556 6449
Email
alzahrahosp@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sajjad Pourasghary
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Library Unit, ImamReza Hospital, Daneshghah Street, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
0098147585684
Email
pourasghary.s@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.