Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Cervical Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05141136
• Other study ID #: 3-2021-0293
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2021
• Source: Gangnam Severance Hospital
• Contact: Do Hyeong Kim
• Phone: 82-2-2019-4601
• Email: BREADFANS[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Cervical Spinal Stenosis
• Spinal Stenosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure in mmHg	Record blood pressure , and calculate the change from baseline.	Before nerve block, after 30 minutes
Secondary	Pulse rate in /min	Record pulse, and calculate the change from baseline.	Before nerve block, after 30 minutes
Secondary	Presence of adverse events	Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia	Before nerve block, after 30 minutes
Secondary	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