Selective Cervical Root Block for Chronic Pain

Appropriate Sonoanatomical Approach in Ultrasound-guided Selective Cervical Root Block

Currently, selective cervical nerve root injections are recommended under the guidance of fluoroscopy, ultrasonography and computed tomography in patients with chronic cervical radicular pain who do not respond to conservative treatments and are not planned for surgery. Various serious complications, mainly vascular, have been reported in the literature. These complications include vertebral artery injury, spinal cord and brain stem infarction. The arteries of the cervical spinal cord are the vertebral, ascending, and deep cervical arteries arising from the aorta.The arteries arising from these main arteries and reaching the intervertebral foramen are called segmental arteries, the arteries reaching the epidural region from the intervertebral foramen and the radicular arteries, and the branches reaching the spinal cord are called the medullary artery. These small arteries supplying the spinal cord lie close to the spinal nerve in the foramen between the anterior and posterior trabercules. Vasospasm or embolism, which occurs as a result of direct needle trauma to these vascular structures around the target nerve or injection of particulate steroids, are the most common causes of complication development.

The aim of our study is to identify the vascular structures around the foramen in selective cervical root injection, which has proven effectiveness in cervical radicular pain, to determine the most reliable method for positioning the needle while reaching the target nerve under US guidance and to prevent possible complications.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Ultrasound-guided selective cervical nerve root block

Detailed Description

A total of 50 healthy volunteers and 10 patients with cervical radicular pain, between the ages of 18-70, height above 155 cm and body mass index 25 and below, in the Algology Clinic of the University of Health Sciences Dışkapı Yıldırım Beyazıt Training and Research Hospital will be included in the study. Those who have structural disorders in the neck region and who have undergone neck surgery will not be included in the study. 7 cadavers will be included in the study in Ankara University Faculty of Medicine, Department of Anatomy.

2 Algology specialists from Health Sciences University Dışkapı Yıldırım Beyazıt Training and Research Hospital Algology Clinic and 3 doctors from Ankara University Medical Faculty Anatomy Department will participate in the study. Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. Again, two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries.

Demographic characteristics (age, gender, BMI, body height) of 50 volunteers and 10 patients with cervical radicular pain will be recorded. The pain intensity of 10 patients with cervical radicular pain will be determined and recorded with the VAS (visual analog scale) score before the procedure and at 1,2,3 and 4 weeks after the procedure, by calling the patients for control.

The cadavers will be dissected after being placed in the supine position and bilaterally from C4 to C7. Neurovascular complexes will be defined.

Efforts will be made to determine the most appropriate needle pathway to reach the target cervical nerve.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Dişkapi Reserch and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

healthy volunteers numbers30 people 10 individuals with radicular pain 7 cadavers

Description

Inclusion Criteria:

healthy volunteers patients with cervical radicular pain

Exclusion Criteria:

Patients who have structural disorders in the neck region and who have undergone neck surgery

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: healthy volunteers; Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG.
Active Comparator: patients with cervical radicular pain; Two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure.	Procedure: Ultrasound-guided selective cervical nerve root block; The volunteer will be placed in the lateral decubitus position with the examined side up and the ultrasonographic examination will be started. Using a high frequency 6-18 MHz linear transducer, scanning in the cephalad and caudal direction until the cervical tubercles are identified in the short axis of the vertebra at the cricoid level, the localization and number of the target nerve root and vascular structures in the foraminal opening between the anterior and posterior tubercles of the transverse process from C4 to C8. will be defined as Unlike healthy volunteers, local anesthetic and steroid injections will be administered to the target nerve.
Other: human cadavers; Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries.	Procedure: Ultrasound-guided selective cervical nerve root block; The volunteer will be placed in the lateral decubitus position with the examined side up and the ultrasonographic examination will be started. Using a high frequency 6-18 MHz linear transducer, scanning in the cephalad and caudal direction until the cervical tubercles are identified in the short axis of the vertebra at the cricoid level, the localization and number of the target nerve root and vascular structures in the foraminal opening between the anterior and posterior tubercles of the transverse process from C4 to C8. will be defined as Unlike healthy volunteers, local anesthetic and steroid injections will be administered to the target nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the vascular structures around the needle pathway while approaching the nerve to be applied cervical spinal nerve block with a needle.	Will evaluate the vascular structures around each C5, C6, and C7 nerve root , with Doppler ultrasound imaging. The pain scores of the patients will be evaluated with VAS (visual analog scale) by applying cervical root block under the guidance of Doppler USG to patients with cervical radicular pain.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (visual analog scale)	Pre- and post-procedure pain scores of the patients will be evaluated with VAS (visual analog scale) by applying cervical root block under the guidance of Doppler USG to patients with cervical radicular pain.	15 days

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Ömer Taylan Akkaya, Diskapi Yildirim Beyazit Education and Research Hospital; Study Director: Ayhan Cömert, Ankara University Faculty of Medicine; Principal Investigator: Damla Yürük, Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neck pain; Sonoanatomy; Cervical nerve root block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Selective cervical root block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No