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

NCT05145842 | Unknown

• 1 other identifier: 24
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiculopathy; Lumbar Disc Herniation; Spinal Stenosis

Keywords

caudal injection; ultrasound; fluoroscopy

Outcome Measures

Primary Outcomes (1)

• Processing Time

  The time will be measured by a researcher who will be present in the processing room, using a stopwatch. The chronometer will be started by the researcher with the contact of the needle tip with the skin, in which local anesthetic is used, and the time measurement will be terminated when the spinal treatment needle is withdrawn from the patient.

  during the intervention

Secondary Outcomes (4)

• Fluoroscopy Time

  immediately after the intervention

• Kerma-area Product (μGy)

  immediately after the intervention

• Visual Analogue Scale

  baseline, change from baseline VAS at 2 and 8 weeks after intervention

• Oswestry Low Back Pain Disability Questionnaire

  baseline, change from baseline VAS at 2 and 8 weeks after intervention

Study Arms (2)

floroscopy

ACTIVE COMPARATOR

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

Procedure: floroscopy

ultrasound+fluoroscopy

EXPERIMENTAL

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

Procedure: ultrasound+fluoroscopy

Interventions

floroscopy PROCEDURE

After proper antiseptic dressing and draping, sacral hiatus was identified. the position of the needle was confirmed by lateral and anteroposterior fluoroscopic images. The needle was introduced up to S3 level for proper spread of the drug.

floroscopy

ultrasound+fluoroscopy PROCEDURE

After proper antiseptic dressing and draping, the caudal region will be shown in the longitudinal section using sterile probe cover and gel. Under ultrasonographic imaging, the sacrococcygeal ligament will be crossed and the needle will not be advanced any further once the sacral canal is entered. The fluoroscopy phase of the combined imaging will be started and the needle position will be checked by taking an anteroposterior view. The needle tip will be positioned at the sacral 3 level. The needle will be repositioned until the proper position is achieved. The research will be terminated at this point and the time to this stage and the radiation exposure dose will be obtained.

ultrasound+fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement; Spinal Stenosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Serdar Kesikburun, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Esra Celik Karbancioglu, MD

CONTACT

+905058236020; esracelikdr@gmail.com

Serdar Kesikburun, MD

CONTACT

+903122911402; serdarkb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 6, 2021
• Study Start: May 26, 2021
• Primary Completion: February 26, 2022
• Study Completion: May 26, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)