The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Unknown

Conditions: Radiculopathy; Spinal Stenosis; Lumbar Disc Herniation

Treatments: Procedure: floroscopy; Procedure: ultrasound+fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05145842

24

Details and patient eligibility

About

The primary purpose of this study is to asses the effect of caudal epidural injection guided by a combination of ultrasound and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided.

Secondary aims are to reveal the presence of structural variations that prevent injection by examining the morphology of the sacral hiatus by ultrasonography.

Full description

The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Before the procedure, all patients will be scanned with ultrasonography to examine the caudal region morphology.

Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure.

Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged> 18 years
• Participation in the study voluntarily
• Diagnosis of radiculopathy caused by spinal stenosis or disc herniation after physical examination and imaging (BT or MRI)

Exclusion criteria

• Cauda equina syndrome or rapidly progressing neurological deficit
• previous spine surgery
• local site infection
• history of allergy to local anesthetic and contrast agents
• acute or chronic unstable medical disease
• psychiatric illness
• anticoagulant therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

floroscopy

Active Comparator group

Description:

28 patients who have previously been evaluated and planned for caudal epidural injections

Treatment:

Procedure: floroscopy

ultrasound+fluoroscopy

Experimental group

Description:

28 patients who have previously been evaluated and planned for caudal epidural injections

Treatment:

Procedure: ultrasound+fluoroscopy