Comparison of spinal anesthesia in L3-L4 and L4-L5 on sensory- motor block and Hemodynamic state in cesarean section.
Design
70 patients were randomly assigned into 4 blocks in a randomized, double blind randomized clinical trial,In one of the two groups, anesthesia occurs at the level of L3-L4 or L4-L5 under spinal anesthesia.
Settings and conduct
In this study, patients aged 18 to 45 years who are candidates for cesarean section who will be referred to the Fatemiyeh Hospital of Hamedan during the study period, will be randomly assigned to randomized allocation blocks by random sampling.
Participants/Inclusion and exclusion criteria
Inclusin Criteria: parturients aged 18 to 45 years old; Candidates for cesarean section under spinal anesthesia; ASA Physical Class 1 and 2. Exclusion Criteria: Heart disease; Hypertension; Eclampsia & pre-eclampsia; Diabetes; Those who are reluctant to continue to participate in the study; Patients who have failed spinal anesthesia and undergo general anesthesia; Spinal anesthesia Contraindications (High ICP, coagulation problems, shock, anemia)
Intervention groups
Case group: Patients undergoing cesarean section under spinal anesthesia in L3-L4 space.
Control group: Patients undergoing cesarean section under spinal anesthesia in L4-L5 space.
Main outcome variables
Sensory block level, motor block level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120915010841N15
Registration date:2019-03-27, 1398/01/07
Registration timing:registered_while_recruiting
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of spinal anesthesia in L3-L4 and L4-L5 on sensory- motor block and Hemodynamic state in cesarean section
Public title
Spinal anesthesia in L3-L4 and L4-L5 on sensory- motor block and Hemodynamic state in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
parturients aged 18 to 45 years old
Candidates for cesarean section under spinal anesthesia
ASA Physical Class 1 and 2
Exclusion criteria:
Heart disease
Hypertension
Eclampsia & pre-eclampsia
Diabetes
Those who are reluctant to continue to participate in the study
Patients who have failed spinal anesthesia and undergo general anesthesia
Spinal anesthesia Contraindications (High ICP, coagulation problems, shock, anemia)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , a randomized block design with four replications is used. we provide four paper sheets . We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two groups, anesthesia at the level of L3-L4 or L4-L5, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups, the patient and the anesthetist nurse who entered the information in the questionnaire, none of the level of SCI performed by the anesthetist was unaware. In addition, the analyzer will not know the results of encoding the intervention and comparison groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of medical sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.958
Health conditions studied
1
Description of health condition studied
Spinal anesthesia in cesarean section
ICD-10 code
o74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
Maximum sensory leveL
Timepoint
Every minute to 5 minutes
Method of measurement
Determination of sensory level by needle (Pinprick)
2
Description
Onset time of sensory block
Timepoint
Every minute until the sensory block is fixed
Method of measurement
In minutes using the clock
3
Description
Systolic and Diastolic Blood Pressure
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device
4
Description
Heart Rate
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
after delivery
Method of measurement
View and ask the patient
2
Description
Need for ephedrine
Timepoint
End of surgery
Method of measurement
Calculate consumed ephedrine
3
Description
Need for atropine
Timepoint
End of surgery
Method of measurement
Calculate consumed atropine
Intervention groups
1
Description
Intervention group: Patients undergoing cesarean section under spinal anesthesia in L3-L4 space.
Category
Prevention
2
Description
Control group: Patients who underwent cesarean section under spinal anesthesia in L4-L5 space.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Fatemy Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available