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Effect of caudal volume injecton on optic nerve sheath diameter in pateints with failed back surgery syndrome

Protocol summary

Study aim
Effect of caudal injection on the diameter of the optic nerve sheath in patients with failed back surgery syndrome
Design
A clinical trial study on 46 patients without a control group, not randomized from July9,2024 to January9, 2024
Settings and conduct
In the pain department of Imam Hossain Hospital of Shahid Behshti University of Medical Sciences ,after obtaining written consent and absence of exclusion criteria, age, sex, body mass index ,systolic, diastolic and mean arterial blood pressure and heart rate, as well as optic nerve sheath diameter are measured with a linear ultrasound probe before caudal injection in the supine position and are recorded.Then, for all patients with failed lumbar surgery syndrome, 30 ml containing 1500 units of hyaluronidase and normal saline in a volume of 10 ml, 40 mg of methylprednisolone and %0.2 ropivacaine to a volume of 10 ml and after 20 minutes, 10 ml of 5% sodium chloride is injected in prone position in the caudal epidural space using a 22-gauge spinal cutting needle and ultrasound guidance.Then, in supine position immediately and in 10, 20 and 40 minutes after the caudal injection,above parameters are measured .
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients between the ages of 18 and 60 to treatment of failed back surgery syndrome with using caudal injection .Exclusion criteria: coagulation disorders, infection in the sacrum ,systemic infection
Intervention groups
Patients aged 18 to 60 to the treatment of failed back surgery syndrome with using caudal epidural injection
Main outcome variables
Change in intracranial pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240609062049N1
Registration date: 2024-09-28, 1403/07/07
Registration timing: registered_while_recruiting

Last update: 2024-09-28, 1403/07/07
Update count: 0
Registration date
2024-09-28, 1403/07/07
Registrant information
Name
Sayed mohammad reza Razavizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 9217
Email address
mr_razavi48@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of caudal volume injecton on optic nerve sheath diameter in pateints with failed back surgery syndrome
Public title
Effect of caudal volume injection on optic nerve sheath diameter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years Suffering from failed back surgery syndrome Candidate for epidural adhesion removal by caudal epidural injection
Exclusion criteria:
coagulation disorders occupational brain lesions lncreased intracranial pressure infection of sacrum area systemic infections optic nerve diseases cauda equina syndrome cerbrovascular diseases uncontrolled arterial hypertension ischemic heart disease and or cardiac arrythmias
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shaid Beheshti University of Medical Sciences
Street address
Shahid madani street - Emam hossain hospital
City
Tehran
Province
Tehran
Postal code
6314116177
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.077

Health conditions studied

1

Description of health condition studied
Optic nerve sheath diameter
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Optic nerve sheath diameter
Timepoint
Before intervention, immediately,10,20,40 minutes after intervention
Method of measurement
ultrasonography

2

Description
optic nerve sheath diameter
Timepoint
pervious , ultimate , 10 ,20 and 40 minutes after caudal iniection
Method of measurement
ultrasonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 ml of solution containing 1500 units of hyaluronidase made by WOCKHARDT.UK in a volume of 10 ml within 2 minutes, 10 ml of rovacaine 0.2% made by Varian pharmed along with 40 mg of methylprednisolone made by Iranhormone pharmaceutical co. within 2 minutes and then From 20 minutes, 10 ml of 5% sodium chloride manufactured by SAMEN Pharmaceutical Co. It is injected once in 2 minutes in the caudal epidural space.Send feedback
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam hosain hospital
Full name of responsible person
Sayed mohammad reza razavizadeh
Street address
Shahi madani street
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
mr_razavi48@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayed mohammad reza razavizadeh
Street address
Shahid madani street
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
mr_razavi48@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayed mohammad reza razavizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid madani street
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
mr_razavi48@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayed mohammad reza Razvizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid madani street
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
098 21 73433000
Email
mr_razavi48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayed mohammad reza Razavizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid madani street
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
mr_razavi48@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the data is specific to this study and cannot be given to other researchers from an ethical point of view.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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