Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05141136

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spinal Stenosis	Procedure: Ultrasound probe sagittal group Procedure: Ultrasound probe transverse group	N/A

Detailed Description

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 monthsPatients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and those who analyze magnetic resonance imaging, are kept unaware of group assignments.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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, )
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.
Blood pressure in mmHg [Before nerve block, after 30 minutes]
Record blood pressure , and calculate the change from baseline.
Pulse rate in /min [Before nerve block, after 30 minutes]
Record pulse, and calculate the change from baseline.
Presence of adverse events [Before nerve block, after 30 minutes]
Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Do-Hyeong Kim, Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05141136

Other Study ID Numbers:

3-2021-0293

First Posted:

Dec 2, 2021

Last Update Posted:

Dec 2, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Stenosis

Study Results

No Results Posted as of Dec 2, 2021