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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia, Epidural
• Intervention / Treatment: Device: Straight needle; Device: Bent needle

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 Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saeyoung Kim; Phone Number: +82-53-420-5873; Email: saeyoungkim7@gmail.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-412
    • Recruiting
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Straight needle; 25 gauge straight chiba needle	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.
Active Comparator: Bent needle; 25 gauge bent chiba needle	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Medial epidural spreading	Medial epidural spreading is defined as contrast filling the inner side of the pedicle medial margin	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.	During procedure

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-03-022-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No