Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Study Overview
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Brief Summary
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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
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Ultrasound guided thoracic 2 paravertebral block will be done using sagittal scan or transverse scan. Clinical parameters will be monitored (temperature, perfusion index, assessment of sensory block and analgesic effect, vital sign, adverse events) after the nerve block. Cervical MRI will be taken 1 hour after the nerve block. Follow up 7 days and 28 days after the MRI at outpatient clinic (numeric rating scale, medication quantification scale)

Official Title
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A Magnetic Resonance Imaging Study of the Spread of Local Anesthetic Solution in Patients Receiving Ultrasound-guided Paravertebral Block at the Thoracic 2 Spinal Level: Prospective Randomized Controlled Study

Conditions
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Cervical Spinal Stenosis

Intervention / Treatment
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* Procedure: Ultrasound probe sagittal group
* Procedure: Ultrasound probe transverse group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment Diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy Numeric rating score ≥ 4 19 years or older Exclusion Criteria: Cervical or upper thoracic spine surgical history If the body mass index is 35 kg/m2 or more If you have an allergy or hypersensitivity reaction to a local anesthetic coagulation disorders Local infection at the injection site claustrophobia If you have a metal insert such as a pacemaker pregnancy Patients who are unable to communicate and have cognitive impairment If a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound probe sagittal group<br>A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe. | Procedure: Ultrasound probe sagittal group<br>* Place the ultrasound probe vertically against the patient's spine and insert the needle in-plane. The width of insertion of the needle is usually approximately 5 cm from the midline. After the needle penetrates the superior costovertebral ligament and pops, when it reaches the thoracic paravertebral space, perform aspiration and inject 10 mL of 1% lidocaine. At this time, it can be observed in real time as the infusion fluid pushes the bright pleura away from the needle.<br>|
| Active Comparator: Ultrasound probe transverse group<br>A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe. | Procedure: Ultrasound probe transverse group<br>* Place the ultrasound probe transverse to the spine and insert the needle in-plane. The reflection of a transverse process is a common landmark. The needle goes in from lateral to in plane. The goal is a triangle between the parietal pleura anteriorly and the internal intercostal membrane and intercostal muscle posteriorly. The final point of the needle is the transition zone from the intercostal to the thoracic paraspinal space, just anterior to the transverse process. When it is confirmed that the tip of the needle has reached the paravertebral space, 10 mL of 1% lidocaine is injected after checking the negative pressure, and after confirming the spread of the drug in real time with ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injectate spread on MRI imge | Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space) | 1 hour after thoracic 2 paravertebral block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating score | A score of 0 indicates no pain and a score of 10 indicates maximum pain. | Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day. | 
| perfusion index | 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, ) | Before nerve block, after 30 minutes | 
| skin temperature | 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. | Before nerve block, after 30 minutes | 
| pinprick and cold test | 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. | Before nerve block, after 30 minutes | 
| Blood pressure in mmHg | Record blood pressure , and calculate the change from baseline. | Before nerve block, after 30 minutes | 
| Pulse rate in /min | Record pulse, and calculate the change from baseline. | Before nerve block, after 30 minutes | 
| Presence of adverse events | Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia | Before nerve block, after 30 minutes | 
| medication quantification scale | The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations. | Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day |