Cervical Spinal Stenosis
Conditions
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)
Interventions
PROCEDUREUltrasound 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.
PROCEDUREUltrasound 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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Blood pressure in mmHg | Before nerve block, after 30 minutes | Record blood pressure , and calculate the change from baseline. |
Countries
South Korea
Contacts
Primary ContactDo Hyeong Kim
Outcome results
None listed