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A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05260294
Enrollment
45
Registered
2022-03-02
Start date
2019-08-19
Completion date
2019-10-08
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Radiculopathy, Disc Prolapse With Radiculopathy, Neck Pain

Keywords

Fluoroscopy only, cervical epidural steroid injection, contrast spread technique, loss of resistance technique, epidural space identification

Brief 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.

Detailed description

The study participants were patients of Astoria Pain Management, New York, USA (age 28-72 years) with a clinical diagnosis of cervical radiculitis. The Canadian SHIELD Ethics Review Board approved this study (July 18, 2019. REB tracking number: 19-06-002), conducted from August 19, 2019, to October 8, 2019. There was no funding for this study. Patients were eligible for the study if they met the criteria for cervical ESI, which included clinical and recent MRI findings confirming the diagnosis of cervical radiculitis and inadequate pain relief with conservative care for more than 3 months. Other criteria were if the procedure was covered by medical insurance, and if they signed informed consent. Patients were excluded from the study if they were taking anticoagulants or had serious comorbidities such as congestive heart failure. The patients were divided into two groups of 20 each and underwent CESI with either an 18G or a 25G Tuohy needle. The skin was anesthetized with 1% lidocaine in the 18G group but not in the 25G group. All cervical epidurals were performed utilizing the fluoroscopy only method when the needle was navigated from the skin toward the epidural space under contralateral oblique fluoroscopy \[3\], and the contrast spread technique \[4,5\] 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). I utilized the Epidrum device as I consider it a more objective and reproducible method for epidural space identification independent of the provider's skill with the LORT, and because its success rate is comparable to the results attained by trained anesthesiologists employing the LOR syringe \[6, 7, 8\]. Subsequently, accompanied by the radiology assistant, I observed the Epidrum for 30 seconds or more; if the Epidrum deflated, the result was positive. However, if the device remained inflated, the result was reported as negative. The collected data was then analyzed.

Interventions

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

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.

Sponsors

Yakov Perper, MD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The patients were divided into two groups of 20 each and underwent CESI with either an 18G or a 25G Tuohy needle.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical and recent MRI findings confirming the diagnosis of cervical radiculitis * Inadequate pain relief with conservative care for more than 3 months * Signed informed consent * The procedure was covered by medical insurance

Exclusion criteria

* Bleeding disorder or anticoagulants therapy * Serious comorbidities such as congestive heart failure * Pregnancy * Uncontrolled diabetes mellitus * Refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Confirmation of the LOR with epidurally located 18G Tuohy needle by the Epidrum device.30 secondsCervical 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.
Confirmation of the LOR with epidurally located 25G Tuohy needle by the Epidrum device.30 secondsCervical 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026