The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique

Lumbosacral Radicular Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926470
• Other study ID #: 4-2013-0310
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 24, 2014
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

• pregnancy

• coagulopathy

• systemic infection

• any active infection at the injection site

• history of allergy to contrast media, local anesthetics, corticosteroid

• patients unable to communicate or patients with cognitive dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Lumbosacral Radicular Pain

Intervention

Procedure:
• anteroposterior approach group
anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy
• oblique approach group
oblique approach group (n=104): same as anteroposterior approach group except using oblique view

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of intravascular injection	the incidence of intravascular injection in the anteroposterior approach group and the oblique approach group	5 seconds after injection of contrast media via block needle.	No