Comparison of Epidural Needle Placement and Reliability in Interlaminar Epidural Steroid İnjection in the Cervical Region with the Hanging Drop and Loss of Resistance Methods Accompanied by Fluoroscopy in the Prone Position - Prospective Randomized Controlled Clinical Study
The two most commonly used techniques for epidural injection are loss of resistance (LOR) and hanging drop (HD) techniques. Hoffman et al. Determined that the LOR technique in the lateral position has a lower dural risk compared to HD. In the meta-analysis study conducted by Ludmil Todorov et al., It was stated that the HD technique can be preferred in the sitting position because the intrinsic negative pressure is more obvious in the cervical and thoracic epidural area, and there is no evidence regarding the advantage of the HD technique over the LOR in the lumbar area. No study was found in the literature examining the epidural placement and reliability of the needle in the Interlaminar Epidural Steroid Injection applied in the cervical region with the hanging drop and loss of resistance techniques under fluoroscopy in the prone position. In this study, we aimed to investigate which technique is more suitable for determining the epidural area with contrast material under fluoroscopy.
Design
Single center, a prospective, observational
Settings and conduct
The patients dont know which technique to apply
Participants/Inclusion and exclusion criteria
Inclusion criteria - Cervical disc herniation
Exclusion criteria - Patients who have had surgery in the cervical region
Intervention groups
After the patients are laid face down and the neck area is sterilized, the area to be entered is numbed with local anesthesia, then an epidural steroid injection is made to this area using the Hanging Drop or Lost of resistance method under fluoroscopy.
Main outcome variables
1. Which technique is more reliable? 2. What are the possible complications?
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240503061634N1
Registration date:2024-09-23, 1403/07/02
Registration timing:registered_while_recruiting
Last update:2024-09-23, 1403/07/02
Update count:0
Registration date
2024-09-23, 1403/07/02
Registrant information
Name
Shahin Azizov
Name of organization / entity
EGE hospital
Country
Azerbaijan
Phone
+994 51 435 79 75
Email address
shahinazizov1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-08, 1403/03/19
Expected recruitment end date
2024-09-30, 1403/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Epidural Needle Placement and Reliability in Interlaminar Epidural Steroid İnjection in the Cervical Region with the Hanging Drop and Loss of Resistance Methods Accompanied by Fluoroscopy in the Prone Position - Prospective Randomized Controlled Clinical Study
Public title
Cervical Epidural İnjection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
cervical disc herniation
Exclusion criteria:
Operated cervical disc herniation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be provided as follows. Patients will be processed consecutively, one with the LOR method and the other with the HD method. The number of patients to be included will be determined at the study time by performing a power analysis.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know which method will be used
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azerbaijan Medical University
Street address
9RWM+64M Samad Vurgun
City
Baku
Postal code
1022
Approval date
2024-06-07, 1403/03/18
Ethics committee reference number
33
Health conditions studied
1
Description of health condition studied
cervical disc displacement
ICD-10 code
M50.20
ICD-10 code description
Other cervical disc displacement, unspecified cervical region
Primary outcomes
1
Description
Whether the tip of the needle is in the epidural area
Timepoint
At the time of the procedure and after 3 weeks
Method of measurement
Will be evaluated by spreading the contrast over the required area
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Steroid injection will be made into the cervical epidural area with the LOR technique. If the contrast given without pressure loss is in the epidural space, it is considered unsuccessful, and if the contrast given despite pressure loss is not in the epidural space, or even if it is suspicious epidural, it is considered unsuccessful. If there is a pressure loss, if the contrast given is in the epidural space, the procedure will be considered successful. Post-procedure complications will also be examined. Intervention group2: Steroid injection will be made into the cervical epidural space with the HD technique. If the fluid in the Hub part of the needle falls with negative pressure in the HD technique and we see the given contrast in the epidural area with fluoroscopy, the procedure will be considered successful. If the contrast spreads into the epidural space without falling or if the contrast does not spread into the epidural space while falling or if it is suspicious epidural, the procedure will be considered unsuccessful.Post-procedure complications will also be examined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ege hospital
Full name of responsible person
Sahin AZIZOV
Street address
Hasan Aliyev 38
City
Baku
Postal code
35100
Phone
+994 51 435 79 75
Email
shahinazizov1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
EGE
Full name of responsible person
Sahin AZIZOV
Street address
Mohsun senanı
City
Baku
Postal code
1052
Phone
+994 51 435 79 75
Email
shahinazizov1@gmail.com
Web page address
https://agrihekimi.az/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ege
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ege
Full name of responsible person
Sahin Azizov
Position
Fellow MD
Latest degree
Specialist
Other areas of specialty/work
Pain doctor
Street address
Mosun senani
City
Baku
Province
Nerimanov
Postal code
1005
Phone
+994 51 435 79 75
Email
shahinazizov1@gmail.com
Web page address
https://agrihekimi.az/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azerbaijan Medical University
Full name of responsible person
Sahin Azizov
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mohsun Senani
City
Baku
Province
Nesimi
Postal code
1007
Phone
+994 70 660 19 19
Email
shahinazizov1@gmail.com
Web page address
https://alqologiya.az/
Person responsible for updating data
Contact
Name of organization / entity
Azerbaijan Medical University
Full name of responsible person
Sahin Azizov
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mohsun Senani 100
City
Baku
Province
Nerimanov
Postal code
1007
Phone
+994 70 660 19 19
Email
shahinazizov1@gmail.com
Web page address
https://agrihekimi.az/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Comparison of Epidural Needle Placement and Reliability in Interlaminar Epidural Steroid İnjection in the Cervical Region with the Hanging Drop and Loss of Resistance Methods Accompanied by Fluoroscopy in the Prone Position - Prospective Randomized Controlled Clinical Study
When the data will become available and for how long
Made available (starting 3 months after publication)
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
Prospective Randomized Controlled Clinical Study
From where data/document is obtainable
shahinazizov1@gmail.com
What processes are involved for a request to access data/document
The data will be officially available after sending a message to the e-mail