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

Analgesia, Epidural Clinical Trial

Official title:

The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849324
• Other study ID #: 2023-03-022-001
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Kyungpook National University Hospital
• Contact: Jimin Heo
• Phone: +82-53-420-5430
• Email: knuhmrc[@]knu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Related Conditions & MeSH terms

• Analgesia, Epidural

Intervention

Device:
• Straight 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.
• Bent 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravascular injection	Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy	During procedure
Secondary	Ventral epidural spreading	Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view.	up to 24 weeks
Secondary	Medial epidural spreading	Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin	up to 24 weeks
Secondary	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.	During procedure