Analgesia, EpiduralNCT05849324
Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles
A study testing Straight needle and Bent needle in people with Analgesia, Epidural, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Straight needle and Bent needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2023to 31 Dec 2023
- 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 with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.
Who cannot join
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook national university hospital
Daegu, 700-412
Jimin Heo, 82-53-420-5430, knuhmrc@knu.ac.kr
About this study
Official title: The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Read the detailed description
Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% ~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
- Conditions
- Analgesia, Epidural
- Being tested
- Straight needle, Bent needle
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight needleDevice
Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used.
Bent needleDevice
Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used.
| Study group | Role | What they receive |
|---|---|---|
| Straight needle | Experimental | 25 gauge straight chiba needle Receives: Device: Straight needle |
| Bent needle | Active comparator | 25 gauge bent chiba needle Receives: Device: Bent needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravascular injection
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
Measured: During procedure
Secondary outcomes (3)
Ventral epidural spreading
Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view.
Measured: up to 24 weeks
Medial epidural spreading
Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin
Measured: up to 24 weeks
Procedure time
Procedure time is defined as the time from the point when the block needle passed through the skin to observation of the complete contrast flow pattern with real time fluoroscopy.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start27 Apr 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeyoung Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Saeyoung Kim, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849324
- Sponsor's protocol ID
- 2023-03-022-001
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study
- ClinicalTrials.gov ID
- NCT05849324
- Acronym / sponsor ID
- 2023-03-022-001
- Conditions
- Analgesia, Epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 May 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 primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Detailed description
Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% ~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straight needle | Experimental | Device: Straight needle25 gauge straight chiba needle |
| Bent needle | Active comparator | Device: Bent needle25 gauge bent chiba needle |
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 with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.
Key exclusion criteria (1 listed)
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
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 |
|---|---|---|
| Straight needleLumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used. | Device | Straight needle |
| Bent needleLumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used. | Device | Bent needle |
Primary outcome
Intravascular injection
Time frame: During procedure
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
3 secondary outcomes
Ventral epidural spreading
Time frame: up to 24 weeks
Medial epidural spreading
Time frame: up to 24 weeks
Procedure time
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
Related trials for Analgesia, Epidural
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
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.
Saeyoung Kim principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straight needle and Bent needle in people with Analgesia, Epidural, run by Kyungpook National University 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 1 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 8 May 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 Jimin Heo (+82-53-420-5430, knuhmrc@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravascular injection (time frame: During 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 8 May 2023.