A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

February 18, 2022 updated by: Yakov Perper, MD

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Astoria, New York, United States, 11102
        • Astoria Pain Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 18 Gauge Tuohy group
In the 18G group, all CESIs were performed utilizing the fluoroscopy only method when the needle was navigated from the skin toward the epidural space under contralateral oblique fluoroscopy, and 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).
Procedure: Epidural 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.
Active Comparator: 25 Gauge Tuohy group
In the 25G group, all CESIs were performed utilizing the fluoroscopy only method when the needle was navigated from the skin toward the epidural space under contralateral oblique fluoroscopy, and 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).
Procedure: Epidural 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of the LOR with epidurally located 18G Tuohy needle by the Epidrum device.
Time Frame: 30 seconds
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.
30 seconds
Confirmation of the LOR with epidurally located 25G Tuohy needle by the Epidrum device.
Time Frame: 30 seconds
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.
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yakov Perper, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Actual)

October 8, 2019

Study Completion (Actual)

October 8, 2019

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-06-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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