Clinical trial NCT05141136: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spinal Stenosis
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months
Primary purpose: TREATMENT

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: 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)

Eligibility criteria: 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.)

Primary outcomes:
measure: Injectate spread on MRI imge
timeFrame: 1 hour after thoracic 2 paravertebral block
Secondary outcomes:
measure: numeric rating score
timeFrame: Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.
measure: perfusion index
timeFrame: Before nerve block, after 30 minutes
measure: skin temperature
timeFrame: Before nerve block, after 30 minutes
measure: pinprick and cold test
timeFrame: Before nerve block, after 30 minutes
measure: Blood pressure in mmHg
timeFrame: Before nerve block, after 30 minutes
measure: Pulse rate in /min
timeFrame: Before nerve block, after 30 minutes
measure: Presence of adverse events
timeFrame: Before nerve block, after 30 minutes
measure: medication quantification scale
timeFrame: Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References: