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A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

Primary Purpose

Cervical Radiculopathy, Neck Pain, Disc Prolapse With Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural space identification with cervical epidural steroid injection employing CST and LORT.
Sponsored by
Yakov Perper, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Radiculopathy focused on measuring Fluoroscopy only, cervical epidural steroid injection, contrast spread technique, loss of resistance technique, epidural space identification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Astoria Pain Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

18 Gauge Tuohy group

25 Gauge Tuohy group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2022
Last Updated
February 18, 2022
Sponsor
Yakov Perper, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05260294
Brief Title
A Comparison Study Between Contrast Spread and Loss of Resistance Techniques
Official Title
Identification of Epidural Space: A Comparison Study Between Contrast Spread and Loss of Resistance Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yakov Perper, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy, Neck Pain, Disc Prolapse With Radiculopathy
Keywords
Fluoroscopy only, cervical epidural steroid injection, contrast spread technique, loss of resistance technique, epidural space identification

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were divided into two groups of 20 each and underwent CESI with either an 18G or a 25G Tuohy needle.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18 Gauge Tuohy group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
25 Gauge Tuohy group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Epidural space identification with cervical epidural steroid injection employing CST and LORT.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Confirmation of the LOR with epidurally located 18G Tuohy needle by the Epidrum device.
Description
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.
Time Frame
30 seconds
Title
Confirmation of the LOR with epidurally located 25G Tuohy needle by the Epidrum device.
Description
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.
Time Frame
30 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Astoria Pain Management
City
Astoria
State/Province
New York
ZIP/Postal Code
11102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10690148
Citation
Hoffmann VL, Vercauteren MP, Vreugde JP, Hans GH, Coppejans HC, Adriaensen HA. Posterior epidural space depth: safety of the loss of resistance and hanging drop techniques. Br J Anaesth. 1999 Nov;83(5):807-9. doi: 10.1093/bja/83.5.807.
Results Reference
result
PubMed Identifier
30282397
Citation
Doan L, Patel H, Aronova Y, Gharibo C. Variations in Interlaminar Epidural Steroid Injection Practice Patterns by Interventional Pain Management Physicians in the United States. Pain Physician. 2018 Sep;21(5):E493-E499.
Results Reference
result
PubMed Identifier
22994264
Citation
Furman MB, Jasper NR, Lin HW. Fluoroscopic contralateral oblique view in interlaminar interventions: a technical note. Pain Med. 2012 Nov;13(11):1389-96. doi: 10.1111/j.1526-4637.2012.01484.x. Epub 2012 Sep 19. Erratum In: Pain Med. 2013 Oct;14(10):1614. Furman, Michael [corrected to Furman, Michael B].
Results Reference
result
PubMed Identifier
25651004
Citation
Perper Y. Contrast spread technique. Pain Med. 2015 Apr;16(4):827-8. doi: 10.1111/pme.12650. Epub 2015 Feb 4. No abstract available.
Results Reference
result
PubMed Identifier
26849949
Citation
Perper Y. Contrast Spread Technique: Evolution. Pain Med. 2016 Jul;17(7):1385-1386. doi: 10.1093/pm/pnv100. Epub 2016 Feb 5. No abstract available.
Results Reference
result
PubMed Identifier
28891544
Citation
Kartal S, Kosem B, Kilinc H, Kosker H, Karabayirli S, Cimen NK, Demircioglu RI. Comparison of Epidrum, Epi-Jet, and Loss of Resistance syringe techniques for identifying the epidural space in obstetric patients. Niger J Clin Pract. 2017 Aug;20(8):992-997. doi: 10.4103/1119-3077.214366.
Results Reference
result
PubMed Identifier
22558497
Citation
Kim SW, Kim YM, Kim SH, Chung MH, Choi YR, Choi EM. Comparison of loss of resistance technique between Epidrum(R) and conventional method for identifying the epidural space. Korean J Anesthesiol. 2012 Apr;62(4):322-6. doi: 10.4097/kjae.2012.62.4.322. Epub 2012 Apr 23.
Results Reference
result
PubMed Identifier
22081113
Citation
Sawada A, Kii N, Yoshikawa Y, Yamakage M. Epidrum((R)): a new device to identify the epidural space with an epidural Tuohy needle. J Anesth. 2012 Apr;26(2):292-5. doi: 10.1007/s00540-011-1278-1. Epub 2011 Nov 13.
Results Reference
result

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A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

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