- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925439
Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection
July 26, 2023 updated by: Do-Hyeong Kim, Gangnam Severance Hospital
Comparison of the Incidence of Intravascular Injection Using the Tuohy and Quincke Needles During Ultrasound-guided S1 Transforaminal Epidural Injection: a Prospective Randomized Controlled Study
Recently, Park et al. introduced a new technique for performing S1 TFESI using ultrasound.
S1 TFESI using ultrasound can be considered to overcome the disadvantages of exposure to radiation.
We hypothesized that the frequency of intravascular injection differs depending on the type of needle during S1 TFESI under ultrasound guidance.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
284
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Do-Hyeong Kim
- Phone Number: 0220196691
- Email: breadfans@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- GangnamSeverance Hospital
-
Contact:
- jiyeong kim
- Phone Number: 82-2-2019-4601
- Email: gsirb@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Patient diagnosed with S1 radiculopathy because S1 root compression was confirmed on MRI and related symptoms 2. NRS of back and/or radiating pain score of 4 or more 3. Patients aged 19 years or older
Exclusion Criteria:
- 1. Cases in which lumbar count is expected to be difficult due to lumbarization, sacralization, or lumbosacral transition 2. When the S1 posterior foramen is not clearly identified on ultrasound 3. Malignancy 4. Systemic infections 5. Bleeding tendency 6. Contrast allergy 7. Pregnant Women 8. If you cannot read or agree to the consent form 9. If you are unable to sign the consent form yourself
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tuohy needle group
Ultrasound-guided S1 transforaminal epidural block with Touhy needle
|
Ultrasound-guided S1 transforaminal epidural block with Touhy needle
|
Active Comparator: Quincke needle group
Ultrasound-guided S1 transforaminal epidural block with Quincke needle
|
Ultrasound-guided S1 transforaminal epidural block with Quincke needle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of intravascular injection
Time Frame: 1 minute after finishing the procedure
|
incidence of intravascular injection during S1 transforaminal epidural block
|
1 minute after finishing the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time required to complete S1 transforaminal epidural block
Time Frame: Baseline, 1 second after the completion of the procedure
|
time required to complete S1 transforaminal epidural block
|
Baseline, 1 second after the completion of the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Do-Hyeong Kim, Yonsei University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2023
Primary Completion (Estimated)
June 22, 2025
Study Completion (Estimated)
June 22, 2025
Study Registration Dates
First Submitted
June 21, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 3-2023-0145
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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