Caudal Epidural BlockNCT05504590
Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection
A study testing Tuohy needle group and Quincke needle group in people with Caudal Epidural Block, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Caudal Epidural Block
- What is being tested?
- Tuohy needle group and Quincke needle group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2022to 21 Dec 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
- When NRS of back and/or radiating pain is 4 or more
- Patients over 19 years of age
Who cannot join
- Malignancy
- Systemic infection
- Bleeding tendency
- Contrast Allergy
- Pregnant women
- If you cannot read or agree to the consent form
- If you cannot sign the consent form yourself
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study
Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.
- Conditions
- Caudal Epidural Block
- Being tested
- Tuohy needle group, Quincke needle group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuohy needle groupDevice
Ultrasound-guided caudal epidural block with Touhy needle
Quincke needle groupDevice
Ultrasound-guided caudal epidural block with Quincke needle
| Study group | Role | What they receive |
|---|---|---|
| Tuohy needle group | Experimental | Ultrasound-guided caudal epidural block with Touhy needle Receives: Device: Tuohy needle group |
| Quincke needle group | Active comparator | Ultrasound-guided caudal epidural block with Quincke needle Receives: Device: Quincke needle group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intravascular injection
incidence of intravascular injection during caudal epidural block
Measured: 1 minute after finishing caudal epidural block
Secondary outcomes (1)
time required to complete caudal epidural block
time required to complete caudal epidural block
Measured: Baseline, 1 second after the completion of caudal epidural block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start31 Aug 2022
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caudal Epidural BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504590
- Sponsor's protocol ID
- 3-2022-0238
- Status last verified
- Dec 2022
- First submitted
- 16 Aug 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Lee JS, Kim JY, Baek JW, Kim HS, Kim DH. Comparison of the incidence of intravascular injection using the Tuohy and Quincke needles during ultrasound-guided caudal epidural block: a prospective randomized controlled study. Reg Anesth Pain Med. 2024 Jan 11;49(1):17-22. doi: 10.1136/rapm-2023-104504.
PubMed 37169489
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05504590
- Acronym / sponsor ID
- 3-2022-0238
- Conditions
- Caudal Epidural Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 17 Aug 2022 (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.
Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuohy needle group | Experimental | Device: Tuohy needle groupUltrasound-guided caudal epidural block with Touhy needle |
| Quincke needle group | Active comparator | Device: Quincke needle groupUltrasound-guided caudal epidural block with Quincke needle |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
- When NRS of back and/or radiating pain is 4 or more
- Patients over 19 years of age
Key exclusion criteria (7 listed)
- Malignancy
- Systemic infection
- Bleeding tendency
- Contrast Allergy
- Pregnant women
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 |
|---|---|---|
| Tuohy needle groupUltrasound-guided caudal epidural block with Touhy needle | Device | Tuohy needle group |
| Quincke needle groupUltrasound-guided caudal epidural block with Quincke needle | Device | Quincke needle group |
Primary outcome
incidence of intravascular injection
Time frame: 1 minute after finishing caudal epidural block
incidence of intravascular injection during caudal epidural block
1 secondary outcome
time required to complete caudal epidural block
Time frame: Baseline, 1 second after the completion of caudal epidural block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 37169489Kim JY, Lee JS, Kim JY, Baek JW, Kim HS, Kim DH. Comparison of the incidence of intravascular injection using the Tuohy and Quincke needles during ultrasound-guided caudal epidural block: a prospective randomized controlled study. Reg Anesth Pain Med. 2024 Jan 11;49(1):17-22. doi: 10.1136/rapm-2023-104504.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuohy needle group and Quincke needle group in people with Caudal Epidural Block, run by Gangnam Severance 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of intravascular injection (time frame: 1 minute after finishing caudal epidural block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504590, which also lists 1 linked publication.
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 27 Dec 2022.