Study of the effect of spinal needle type on the incidence of transient neurologic syndrom in spinal anesthesia
Design
This study is a triple-blinded clinical trial. The study population included all patients referring to lower limb surgery ward of Imam Reza hospital of Kermanshah city.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is triple-blinded one, that the participants, the researcher, and the evaluator will kept blinded to the intervention groups. Anesthesia segmentation level is measured by using cold-cottoned alcohol bilaterally every 5 minutes for 20 minutes and then every 15 minutes until the complete recovery, the sensory and motor block will be measured and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 18 and 60 years;ASA Class 1; BMI<25
Exclusion criteria: Taking opium; The presence of discopathy and chronic low back pain and previous lower limb pain
Intervention groups
In the first intervention group, anesthetic injections will be performed using the Quincke type G25 needle. Spinal anesthesia is injected in all patients in the L4 -L5 intervertebral lumbar region as the midline aperture, and after exiting, a small amount of CSF is injected with 0.5% bupivacaine at 12.5 mg/sec at 0.2 mg/sec
In the second intervention group, anesthetic injections will be performed using the Sprutte type G25 needle. Spinal anesthesia is injected in all patients in the L4- L5 intervertebral lumbar region as the midline aperture, and after exiting, a small amount of CSF is injected with 0.5% bupivacaine at 12.5 mg/sec at 0.2 mg/sec.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100101002946N9
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-16, 1397/06/25
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of spinal needle type on the incidence of Transient Neurologic Syndrom in spinal anesthesia.
Public title
The effect of type of anesthetic needle on spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class 1
BMI<25
Aged between 18 and 60 years
Exclusion criteria:
Coagulation disorders
Taking opium
The presence of discopathy and chronic low back pain and previous lower limb pain
Duration of operation more than 2 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
150
Actual sample size reached:
150
More than 1 sample in each individual
Actual sample size in each individual:
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt.Selecting people randomly runs from one table point to the row or column by closing the eye and inserting a finger or pen tip on the table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, investigator, and clinical caregiver will be blinded to the study groups, the drug dose, and the drug manufacturer.In fact, factors that could distort the test result are hidden from the eyes of the researcher, patients, and clinical caregivers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.KUMS.REC.1397.005
Health conditions studied
1
Description of health condition studied
Postoperative pain in orthopaedic lower limb surgery
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes
Primary outcomes
1
Description
Intensity of pain
Timepoint
The end of study
Method of measurement
Base on visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, anesthetic injections will be performed using the Quincke type G25 needle. Spinal anesthesia is injected in all patients in the L4 -L5 intervertebral lumbar region as the midline aperture, and after exiting, a small amount of CSF is injected with 0.5% bupivacaine at 12.5 mg/sec at 0.2 mg/sec.
Category
Other
2
Description
In the second intervention group, anesthetic injections will be performed using the Sprutte type G25 needle. Spinal anesthesia is injected in all patients in the L4- L5 intervertebral lumbar region as the midline aperture, and after exiting, a small amount of CSF is injected with 0.5% bupivacaine at 12.5 mg/sec at 0.2 mg/sec.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Somaye Ziaie
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
somaye.ziaie@yshoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Somaye Ziaie
Position
Residents Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
somaye.ziaie@yshoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
myari@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Somaye Ziaie
Position
Residents Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
somaye.ziaie@yshoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail