The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections
NCT ID: NCT05145842
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2021-05-26
2022-05-26
Brief Summary
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Secondary aims are to reveal the presence of structural variations that prevent injection by examining the morphology of the sacral hiatus by ultrasonography.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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floroscopy
28 patients who have previously been evaluated and planned for caudal epidural injections
floroscopy
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.
ultrasound+fluoroscopy
28 patients who have previously been evaluated and planned for caudal epidural injections
ultrasound+fluoroscopy
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.
Interventions
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floroscopy
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.
ultrasound+fluoroscopy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Associate professor
Principal Investigators
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Serdar Kesikburun, MD
Role: STUDY_DIRECTOR
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Locations
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SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Esra Celik Karbancioglu
Role: primary
Other Identifiers
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24
Identifier Type: -
Identifier Source: org_study_id