- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05108103
Determination of Longus Colli Muscle Thickness by Ultrasonography
How Far Should The Needle Be Withdrawn for Stellate Ganglion Block: Determination of Longus Colli Muscle Thickness by Ultrasonography
Study Overview
Status
Detailed Description
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.
In 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process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.
The 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 How far should the needle be withdrawn?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.
The 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Halil Çetingök
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 - 65 years,
- Giving informed consent for examination, ultrasonographic evaluation and study participation
Exclusion Criteria:
- Having a chronic neck pain for more than 6 months,
- 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.)
- Having a history of surgery or radiation therapy in the cervical region
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters)
Time Frame: 0 minutes
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Distance between corpus and longus colli muscle's anterior border on C6 level will be evaluated with ultrasonography.
|
0 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distance between corpus and longus colli muscle's anterior border on C7 level (millimeters)
Time Frame: 0 minutes
|
Distance between corpus and longus colli muscle's anterior border on C7 level will be evaluated with ultrasonography.
|
0 minutes
|
|
Maximum anteroposterior width of longus colli muscle on C6 level (millimeters)
Time Frame: 0 minutes
|
Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.
|
0 minutes
|
|
Maximum anteroposterior width of longus colli muscle on C7 level (millimeters)
Time Frame: 0 minutes
|
Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.
|
0 minutes
|
|
Distance between esophagus and estimated needle plane (millimeters)
Time Frame: 0 minutes
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Distance between esophagus and estimated needle plane will be evaluated with ultrasonography.
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0 minutes
|
|
Neck circumference (centimeters)
Time Frame: 0 minutes
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Neck circumference
|
0 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Halil Çetingök, Ass. Prof., Istanbul University Istanbul Faculty of Medicine, Department of Pain Medicine
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sweat Gland Diseases
- Skin Diseases
- Pain
- Neurologic Manifestations
- Disease
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Hyperhidrosis
- Syndrome
- Complex Regional Pain Syndromes
- Reflex Sympathetic Dystrophy
- Somatoform Disorders
- Pain, Intractable
Other Study ID Numbers
- 2021/182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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