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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05108103
Other study ID # 2021/182
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date June 1, 2022

Study information

Verified date September 2022
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks


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process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.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 How far should the needle be withdrawn?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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Halil Çetingök Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ates Y, Asik I, Ozgencil E, Açar 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters) Distance between corpus and longus colli muscle's anterior border on C6 level will be evaluated with ultrasonography. 0 minutes
Secondary Distance between corpus and longus colli muscle's anterior border on C7 level (millimeters) Distance between corpus and longus colli muscle's anterior border on C7 level will be evaluated with ultrasonography. 0 minutes
Secondary Maximum anteroposterior width of longus colli muscle on C6 level (millimeters) Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography. 0 minutes
Secondary Maximum anteroposterior width of longus colli muscle on C7 level (millimeters) Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography. 0 minutes
Secondary Distance between esophagus and estimated needle plane (millimeters) Distance between esophagus and estimated needle plane will be evaluated with ultrasonography. 0 minutes
Secondary Neck circumference (centimeters) Neck circumference 0 minutes
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