Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05260294
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2022-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Study Between Contrast Spread and Loss of Resistance Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-17', 'size': 516722, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-11T14:58', 'hasProtocol': True}, {'date': '2019-07-18', 'size': 151715, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-18T09:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients were divided into two groups of 20 each and underwent CESI with either an 18G or a 25G Tuohy needle.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of the LOR with epidurally located 18G Tuohy needle by the Epidrum device.', 'timeFrame': '30 seconds', '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.'}, {'measure': 'Confirmation of the LOR with epidurally located 25G Tuohy needle by the Epidrum device.', 'timeFrame': '30 seconds', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluoroscopy only', 'cervical epidural steroid injection', 'contrast spread technique', 'loss of resistance technique', 'epidural space identification'], 'conditions': ['Cervical Radiculopathy', 'Neck Pain', 'Disc Prolapse With Radiculopathy']}, 'referencesModule': {'references': [{'pmid': '10690148', 'type': 'RESULT', '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.'}, {'pmid': '30282397', 'type': 'RESULT', '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.'}, {'pmid': '22994264', 'type': 'RESULT', '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.'}, {'pmid': '25651004', 'type': 'RESULT', '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.'}, {'pmid': '26849949', 'type': 'RESULT', '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.'}, {'pmid': '28891544', 'type': 'RESULT', '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.'}, {'pmid': '22558497', 'type': 'RESULT', '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.'}, {'pmid': '22081113', 'type': 'RESULT', '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.'}, {'pmid': '36618582', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and recent MRI findings confirming the diagnosis of cervical radiculitis\n* Inadequate pain relief with conservative care for more than 3 months\n* Signed informed consent\n* The procedure was covered by medical insurance\n\nExclusion Criteria:\n\n* Bleeding disorder or anticoagulants therapy\n* Serious comorbidities such as congestive heart failure\n* Pregnancy\n* Uncontrolled diabetes mellitus\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT05260294', 'briefTitle': 'A Comparison Study Between Contrast Spread and Loss of Resistance Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Astoria Pain Management'}, 'officialTitle': 'Identification of Epidural Space: A Comparison Study Between Contrast Spread and Loss of Resistance Techniques', 'orgStudyIdInfo': {'id': '19-06-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '18 Gauge Tuohy group', '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).', 'interventionNames': ['Procedure: Epidural space identification with cervical epidural steroid injection employing CST and LORT.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25 Gauge Tuohy group', '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).', 'interventionNames': ['Procedure: Epidural space identification with cervical epidural steroid injection employing CST and LORT.']}], 'interventions': [{'name': 'Epidural space identification with cervical epidural steroid injection employing CST and LORT.', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['18 Gauge Tuohy group', '25 Gauge Tuohy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11102', 'city': 'Astoria', 'state': 'New York', 'country': 'United States', 'facility': 'Astoria Pain Management', 'geoPoint': {'lat': 40.77205, 'lon': -73.93014}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yakov Perper, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Astoria Pain Management PLLC, Principal Investigator', 'investigatorFullName': 'Yakov Perper, MD', 'investigatorAffiliation': 'Astoria Pain Management'}}}}