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Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Primary Purpose

Cervical Spinal Stenosis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ultrasound probe sagittal group

Ultrasound probe transverse group

About this trial

This is an interventional treatment trial for Cervical Spinal Stenosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound probe sagittal group

Ultrasound probe transverse group

Arm Description

A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe.

A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe.

Outcomes

Primary Outcome Measures

Injectate spread on MRI imge

Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)

Secondary Outcome Measures

numeric rating score

A score of 0 indicates no pain and a score of 10 indicates maximum pain.

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, )

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.

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.

Blood pressure in mmHg

Record blood pressure , and calculate the change from baseline.

Pulse rate in /min

Record pulse, and calculate the change from baseline.

Presence of adverse events

Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia

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.

Full Information

NCT ID

NCT05141136

First Posted

September 27, 2021

Last Updated

November 18, 2021

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05141136

Brief Title

Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 30, 2021 (Anticipated)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound probe sagittal group

Arm Type

Experimental

Arm Description

A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe.

Arm Title

Ultrasound probe transverse group

Arm Type

Active Comparator

Arm Description

A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound probe sagittal group

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound probe transverse group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Injectate spread on MRI imge

Description

Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)

Time Frame

1 hour after thoracic 2 paravertebral block

Secondary Outcome Measure Information:

Title

numeric rating score

Description

A score of 0 indicates no pain and a score of 10 indicates maximum pain.

Time Frame

Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.

Title

perfusion index

Description

Time Frame