ClinicalTrials.gg
RecruitingNCT05849324Updated May 8, 2023

Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles

An interventional study of Straight needle and Bent needle in Analgesia, Epidural, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-08.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Analgesia, Epidural
03

In context

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, allergic to contrast media, patient refusal, and patients with persistent to nerve block such as coagulopathy and infection of the injection site.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Straight needle

    25 gauge straight chiba needle

    Device: Straight needle

  • Active comparator
    Bent needle

    25 gauge bent chiba needle

    Device: Bent needle

Interventions

  • DeviceStraight needle

    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.

  • DeviceBent needle

    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.

06

What researchers measure

Primary outcomes

  1. Intravascular injection

    Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy

    Time frame: During procedure

Secondary outcomes

  1. Ventral epidural spreading

    Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view.

    Time frame: up to 24 weeks

  2. Medial epidural spreading

    Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin

    Time frame: up to 24 weeks

  3. 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.

    Time frame: During procedure

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Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05849324
Lead sponsor
Kyungpook National University Hospital
Responsible party
Saeyoung Kim, MD, PhD (Professor, Kyungpook National University Hospital) — Principal investigator
First posted
May 8, 2023
Start date
Apr 27, 2023
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 8, 2023

Study contacts

Jimin Heo
Contact
knuhmrc@knu.ac.kr
+82-53-420-5430
Saeyoung Kim
Contact
saeyoungkim7@gmail.com
+82-53-420-5873
Saeyoung Kim
principal investigator · Kyungpook National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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