S1 Transforaminal Epidural InjectionNCT05956054
A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During S1 STE
A study testing needle type in people with S1 Transforaminal Epidural Injection, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are: The main question it aims to answer is: whether there is a difference in intravascular rate between using a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- S1 Transforaminal Epidural Injection
- What is being tested?
- needle type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jun 2023to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital.
Who cannot join
- Patients with a history of allergy to local anesthetics or steroids
- Patients with a history of allergy to contrast media
- Patients with a bleeding tendency
- Patients with symptoms of infection in the sacroiliac region
- Patients under 18 years of age or over 80 years of age
- Patients who are pregnant or planning to become pregnant
- Other medically incapable of consent, such as the mentally retarded.
- Translated with www.DeepL.com/Translator (free version)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
Jinyoung Oh, MD, PhD
About this study
Official title: A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During Sacral 1 Transforaminal Epidural Block
The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are:
The main question it aims to answer is:
- whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection
Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.
- Conditions
- S1 Transforaminal Epidural Injection
- Being tested
- needle type
- Keywords
- S1 transforaminal epidural injection, curved needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle typeOther
straight or curved
| Study group | Role | What they receive |
|---|---|---|
| S1 transforaminal injection with a straight needle | Active comparator | Not described Receives: Other: needle type |
| S1 transforaminal injection with a curved needle | Experimental | Not described Receives: Other: needle type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravasation rate
Measured: in the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start22 Jun 2023
- Primary completion2 Apr 2024 (estimated)
- Study completion2 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S1 Transforaminal Epidural InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyoung Oh, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956054
- Sponsor's protocol ID
- 2023-04-018-001
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intravascular Penetration With Curved Needle and Straight Needle During Sacral 1 Transforaminal Epidural Block
- ClinicalTrials.gov ID
- NCT05956054
- Acronym / sponsor ID
- 2023-04-018-001
- Conditions
- S1 Transforaminal Epidural Injection
- Keywords
- S1 transforaminal epidural injection, curved needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 2 Apr 2024 (estimated)
- Study completion
- 2 Apr 2024 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to compare in intravasation rate during S1 transforaminal epidural injection between using a straight needle and a curved needle. The main question it aims to answer are:
The main question it aims to answer is:
- whether there is a difference in intravascular rate between using a straight needle and a curved needle in S1 transforaminal epidural injection
Participants in this study will be randomly assigned to receive an S1 transforaminal epidural injection using either a straight needle or a curved needle. The researchers will then observe the intravasation rate and compare it between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S1 transforaminal injection with a straight needle | Active comparator | Other: needle type |
| S1 transforaminal injection with a curved needle | Experimental | Other: needle type |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for a lumbar 1 epidural nerve block in the outpatient department of anesthesiology and pain medicine at Kyungpook National University Hospital.
Key exclusion criteria (8 listed)
- Patients with a history of allergy to local anesthetics or steroids
- Patients with a history of allergy to contrast media
- Patients with a bleeding tendency
- Patients with symptoms of infection in the sacroiliac region
- Patients under 18 years of age or over 80 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| needle typestraight or curved | Other | S1 transforaminal injection with a curved needle, S1 transforaminal injection with a straight needle |
Primary outcome
Intravasation rate
Time frame: in the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needle type in people with S1 Transforaminal Epidural Injection, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinyoung Oh, MD, PHD (+82-010-4425-0304, sgcms3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravasation rate (time frame: in the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.