Selective Cervical Root Block for Chronic Pain

NCT ID: NCT05450926

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2023-06-01

Brief Summary

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.

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided selective cervical nerve root block

Intervention Type: PROCEDURE

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.

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.

Group Type: OTHER

Ultrasound-guided selective cervical nerve root block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Damla Yürük

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ömer Taylan Akkaya

Role: STUDY_DIRECTOR

Diskapi Yildirim Beyazit Education and Research Hospital

Ayhan Cömert

Role: STUDY_DIRECTOR

Ankara University Faculty of Medicine

Damla Yürük

Role: PRINCIPAL_INVESTIGATOR

Diskapi Yildirim Beyazit Education and Research Hospital

Locations

Dişkapi Reserch and Education Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Selective cervical root block

Identifier Type: -

Identifier Source: org_study_id