S1 Transforaminal Injection and Vascular Incidence

Not Applicable

Completed

• Conditions: Inadvertent Arterial Puncture
• Interventions: Procedure: tranforaminal epidural injection

• Registration Number: NCT04634955
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15\~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

Detailed Description

Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

Study Timeline

• Study First Submitted: 2020-11-10
• Study Start: 2020-11-15
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• spinal stenosis
• herniated intervertebral disc
• failed back surgery syndrome

Exclusion Criteria

• coagulopathy
• infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S1 transforaminal injection with AP view	tranforaminal epidural injection	S1 transforaminal injection with anteroposterior fluoroscopic view
S1 transforaminal injection with oboique view	tranforaminal epidural injection	S1 transforaminal injection with oblique fluoroscopic view

Primary Outcome Measures

Name	Time	Method
intravascular incidence	15 minutes after the completion of the intervention	intravascular injection rate

Secondary Outcome Measures

Name	Time	Method
radiation dose	15 minutes after the completion of the intervention	radiation dose
procedure time	15 minutes after the completion of the intervention	procedure time

Trial Locations

Locations (1)

Hong ji HEE; 🇰🇷 Daegu, Korea, Republic of