Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Spinal Stenosis
• Intervention / Treatment: Procedure: Ultrasound probe sagittal group; Procedure: Ultrasound probe transverse group

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Do Hyeong Kim; Phone Number: 82-2-2019-4601; Email: BREADFANS@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
    • Contact: jiyeong kim; Phone Number: 82-2-2019-6691; Email: JYJYSY1230@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Ultrasound probe sagittal group; 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.
Active Comparator: 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.	Procedure: Ultrasound probe transverse group; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: 3-2021-0293

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