Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Not Applicable

• Conditions: Cervical Spinal Stenosis
• Interventions: Procedure: Ultrasound probe sagittal group; Procedure: Ultrasound probe transverse group

• Registration Number: NCT05141136
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

The purpose of this study is to analyze the spread of local anesthetic using magnetic resonance imaging after thoracic 2 paravertebral block in patients with cervical radiculopathy.

Detailed Description

1. Ultrasound guided thoracic 2 paravertebral block will be done using sagittal scan or transverse scan.

2. Clinical parameters will be monitored (temperature, perfusion index, assessment of sensory block and analgesic effect, vital sign, adverse events) after the nerve block.

3. Cervical MRI will be taken 1 hour after the nerve block.

4. Follow up 7 days and 28 days after the MRI at outpatient clinic (numeric rating scale, medication quantification scale)

Study Timeline

• Study First Submitted: 2021-09-27
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study Start: 2021-11-30
• Study First Posted: 2021-12-02
• Last Update Posted: 2021-12-02
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment
2. Diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy
3. Numeric rating score ≥ 4
4. 19 years or older

Exclusion Criteria

1. Cervical or upper thoracic spine surgical history
2. If the body mass index is 35 kg/m2 or more
3. If you have an allergy or hypersensitivity reaction to a local anesthetic
4. coagulation disorders
5. Local infection at the injection site
6. claustrophobia
7. If you have a metal insert such as a pacemaker
8. pregnancy
9. Patients who are unable to communicate and have cognitive impairment
10. If a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound probe sagittal group	Ultrasound probe sagittal group	A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe.
Ultrasound probe transverse group	Ultrasound probe transverse group	A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe.

Primary Outcome Measures

Name	Time	Method
Injectate spread on MRI imge	1 hour after thoracic 2 paravertebral block	Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)

Secondary Outcome Measures

Name	Time	Method
skin temperature	Before nerve block, after 30 minutes	Place a touch thermometer (IntelliVue MP70 patient monitor, Philips Healthcare, Best, Netherlands) on the palm of your hand and measure. Calculate the amount of change from the baseline. Record the difference with the contralateral hand.
pinprick and cold test	Before nerve block, after 30 minutes	Pinprick sensation was performed using a 22 gauge short bevel needle. Comparison with the contralateral dermatome. Sensation is rated as 0 (no sensation), 1 (decreased sensation), and 2 (normal). A sensory block is considered successful if the patient reports 0 or 1. Cold sensation is measured in the same way using an ice cube. If there is no difference in the sensation of the treated dermatome compared to the contralateral dermatome.
Presence of adverse events	Before nerve block, after 30 minutes	Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia
numeric rating score	Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.	A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Blood pressure in mmHg	Before nerve block, after 30 minutes	Record blood pressure , and calculate the change from baseline.
perfusion index	Before nerve block, after 30 minutes	After the subject rests in the supine position for about 10 minutes, pulse oximetry is placed on the index finger to record the baseline value. Perfusion index was measured using pulse oximetry (Root®, Masimo Corporation, Irvine, CA, USA). The perfusion index can be a useful indicator for judging the After the subject rests in the supine position for about 10 minutes, pulse oximetry is placed on the index finger to record the baseline value. Perfusion index was measured using pulse oximetry (Root®, Masimo Corporation, Irvine, CA, )
Pulse rate in /min	Before nerve block, after 30 minutes	Record pulse, and calculate the change from baseline.
medication quantification scale	Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day	The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of