A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

NCT05260294 | Completed

• 1 other identifier: 19-06-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  30 seconds

• 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.

  30 seconds

Study Arms (2)

18 Gauge Tuohy group

ACTIVE COMPARATOR

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.

25 Gauge Tuohy group

ACTIVE COMPARATOR

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.

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.

18 Gauge Tuohy group; 25 Gauge Tuohy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yakov Perper, MD: lead

Study Sites (1)

Astoria Pain Management

Astoria, New York, 11102, United States

Location

Related Publications (9)

• 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.

  PMID: 10690148 RESULT

• 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.

  PMID: 30282397 RESULT

• 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.

  PMID: 22994264 RESULT

• 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.

  PMID: 25651004 RESULT

• 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.

  PMID: 26849949 RESULT

• 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.

  PMID: 28891544 RESULT

• 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.

  PMID: 22558497 RESULT

• 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.

  PMID: 22081113 RESULT

• Perper Y. Identification of cervical epidural space: A comparison study between contrast spread and loss of resistance techniques. Front Pain Res (Lausanne). 2022 Dec 20;3:1000209. doi: 10.3389/fpain.2022.1000209. eCollection 2022.

  PMID: 36618582 DERIVED

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Astoria Pain Management PLLC, Principal Investigator

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

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 2, 2022
• Study Start: August 19, 2019
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)