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Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

Y

Yonsei University Health System (YUHS)

Status

Unknown

Conditions

Cervical Spinal Stenosis

Treatments

Procedure: Ultrasound probe sagittal group
Procedure: Ultrasound probe transverse group

Study type

Interventional

Funder types

Other

Identifiers

NCT05141136
3-2021-0293

Details and patient eligibility

About

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.

Full 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)

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups

Ultrasound probe sagittal group
Experimental group
Description:
A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe.
Treatment:
Procedure: Ultrasound probe sagittal group
Ultrasound probe transverse group
Active Comparator group
Description:
A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe.
Treatment:
Procedure: Ultrasound probe transverse group

Trial contacts and locations

1

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Central trial contact

Do Hyeong Kim

Data sourced from clinicaltrials.gov

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