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

Not Applicable

Recruiting

• Conditions: Analgesia, Epidural
• Interventions: Device: Straight needle; Device: Bent needle

• Registration Number: NCT05849324
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

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 Timeline

• Study Start: 2023-04-27
• Study First Submitted: 2023-04-27
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-08
• Last Update Posted: 2023-05-08
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straight needle	Straight needle	25 gauge straight chiba needle
Bent needle	Bent needle	25 gauge bent chiba needle

Primary Outcome Measures

Name	Time	Method
Intravascular injection	During procedure	Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy

Secondary Outcome Measures

Name	Time	Method
Ventral epidural spreading	up to 24 weeks	Ventral epidural spreading is defined when the contrast reached just behind the vertebral body in fluoroscopic lateral view.
Procedure time	During procedure	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.
Medial epidural spreading	up to 24 weeks	Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Korea, Republic of