Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT05108103
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Longus Colli Muscle Thickness by Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters)", 'timeFrame': '0 minutes', 'description': "Distance between corpus and longus colli muscle's anterior border on C6 level will be evaluated with ultrasonography."}], 'secondaryOutcomes': [{'measure': "Distance between corpus and longus colli muscle's anterior border on C7 level (millimeters)", 'timeFrame': '0 minutes', 'description': "Distance between corpus and longus colli muscle's anterior border on C7 level will be evaluated with ultrasonography."}, {'measure': 'Maximum anteroposterior width of longus colli muscle on C6 level (millimeters)', 'timeFrame': '0 minutes', 'description': 'Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.'}, {'measure': 'Maximum anteroposterior width of longus colli muscle on C7 level (millimeters)', 'timeFrame': '0 minutes', 'description': 'Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.'}, {'measure': 'Distance between esophagus and estimated needle plane (millimeters)', 'timeFrame': '0 minutes', 'description': 'Distance between esophagus and estimated needle plane will be evaluated with ultrasonography.'}, {'measure': 'Neck circumference (centimeters)', 'timeFrame': '0 minutes', 'description': 'Neck circumference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stellate Ganglion', 'Longus Colli Muscle', 'Ultrasound'], 'conditions': ['Pain Syndrome', 'Pain, Intractable', 'Complex Regional Pain Syndromes', 'Hyperhidrosis']}, 'referencesModule': {'references': [{'pmid': '19436184', 'type': 'BACKGROUND', 'citation': 'Ates Y, Asik I, Ozgencil E, Acar HI, Yagmurlu B, Tekdemir I. Evaluation of the longus colli muscle in relation to stellate ganglion block. Reg Anesth Pain Med. 2009 May-Jun;34(3):219-23. doi: 10.1097/AAP.0b013e3181a32a02.'}, {'pmid': '24760493', 'type': 'BACKGROUND', 'citation': 'Narouze S. Ultrasound-guided stellate ganglion block: safety and efficacy. Curr Pain Headache Rep. 2014 Jun;18(6):424. doi: 10.1007/s11916-014-0424-5.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks', 'detailedDescription': "Stellate ganglion block is an interventional pain management procedure that is often performed for diagnostic and therapeutic purposes. It has long been performed with the guidance of fluoroscopy, and despite the increasing use of ultrasonography in recent years, fluoroscopy is still the gold standard method.\n\nIn traditional fluoroscopic method, the needle is directed to the transverse process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.\n\nThe ideal placement of the needle should be anterolateral to the longus colli muscle and deep to the prevertebral fascia. Further placement may cause intramuscular spread and superficial placement may cause injection in the carotid sheath or vascular structures. These are the most important reasons for clinical ineffectiveness. How far should the needle be withdrawn? Data is inconsistent in the literature.\n\nThe primary aim of this study is to determine the distance from transverse process to longus colli muscles anterior border and from transverse process to carotid sheath's posterior border. Secondary aim is to investigate the relationship between longus colli muscle thickness and age, gender, height, weight, BMI and neck circumference."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 - 65 years,\n* Giving informed consent for examination, ultrasonographic evaluation and study participation\n\nExclusion Criteria:\n\n* Having a chronic neck pain for more than 6 months,\n* Having any neurological or musculoskeletal conditions that may affect the anatomy of cervical region (cervical disc herniation, torticollis, severe scoliosis, vertebral malformation, spinal stenosis, myopathies, etc.)\n* Having a history of surgery or radiation therapy in the cervical region'}, 'identificationModule': {'nctId': 'NCT05108103', 'briefTitle': 'Determination of Longus Colli Muscle Thickness by Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'How Far Should The Needle Be Withdrawn for Stellate Ganglion Block: Determination of Longus Colli Muscle Thickness by Ultrasonography', 'orgStudyIdInfo': {'id': '2021/182'}}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Halil Çetingök', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Halil Çetingök, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Istanbul Faculty of Medicine, Department of Pain Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Halil Cetingok', 'investigatorAffiliation': 'Istanbul University'}}}}