CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Epidural space identification with cervical epidural steroid injection employing CST and LORT.procedure
Likely dose
Not stated in record
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Search/NCT05260294
NCT05260294N/ACompleted

Identification of Epidural Space: A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

Yakov Perper, MD·interventional·Posted Mar 2, 2022·Updated Mar 2, 2022

In Brief

A clinical study evaluating Epidural space identification with cervical epidural steroid injection employing CST and LORT. for Cervical Radiculopathy and 2 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed Summary

Early epidural space identification is critical to the efficacy and safety of cervical epidural steroid injections (CESI) \[1\]. Currently, the accepted method for epidural space recognition is the loss of resistance technique (LORT). I perform CESIs with fluoroscopy only \[2\]. I hypothesized that the contrast spread technique (CST) might recognize epidural space concurrently with or sooner than LORT. I also suggested that smaller needles might be employed with CST but not with LORT. To test my hypotheses, I conducted a comparison study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 2, 2022
Enrollment StartAug 19, 2019
Primary CompletionOct 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.3 years ago

Interventions

Epidural space identification with cervical epidural steroid injection employing CST and LORT.procedure

Cervical epidural procedure and epidural space recognition were performed utilizing the fluoroscopy only method. With this technique, needle navigation from the skin toward the epidural space is performed under contralateral oblique fluoroscopy. With the needle at the ventral interlaminar line, the contrast spread technique was employed for epidural space identification. After radiological confirmation of the epidural spread, LOR was tested using an Epidrum® device (Exmoor Innovations Ltd., Somerset, UK). Subsequently, accompanied by the radiology assistant, I observed the Epidrum for 30 seconds or more; if the Epidrum deflated, thus confirming LOR, the result was positive. However, if the device remained inflated, the result was reported as negative. The collected data was then analyzed.