Cervical Spinal StenosisNCT05141136
Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block
A study testing Ultrasound probe sagittal group and Ultrasound probe transverse group in people with Cervical Spinal Stenosis, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cervical Spinal Stenosis
- What is being tested?
- Ultrasound probe sagittal group and Ultrasound probe transverse group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Severance Hospital
Seoul
jiyeong kim, 82-2-2019-6691, JYJYSY1230@yuhs.ac
About this study
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
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.
Read the 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)
- Conditions
- Cervical Spinal Stenosis
- Being tested
- Ultrasound probe sagittal group, Ultrasound probe transverse group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound probe sagittal groupProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound probe sagittal group | Experimental | A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe. Receives: Procedure: Ultrasound probe sagittal group |
| Ultrasound probe transverse group | Active comparator | A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe. Receives: Procedure: Ultrasound probe transverse group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injectate spread on MRI imge
Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)
Measured: 1 hour after thoracic 2 paravertebral block
Secondary outcomes (8)
numeric rating score
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Measured: Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.
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, )
Measured: Before nerve block, after 30 minutes
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.
Measured: Before nerve block, after 30 minutes
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.
Measured: Before nerve block, after 30 minutes
Blood pressure in mmHg
Record blood pressure , and calculate the change from baseline.
Measured: Before nerve block, after 30 minutes
Pulse rate in /min
Record pulse, and calculate the change from baseline.
Measured: Before nerve block, after 30 minutes
Presence of adverse events
Horner syndrome, hoarseness, dyspnea, ptosis, dysphagia
Measured: Before nerve block, after 30 minutes
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.
Measured: Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start30 Nov 2021 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141136
- Sponsor's protocol ID
- 3-2021-0293
- Status last verified
- Nov 2021
- First submitted
- 27 Sep 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05141136
- Acronym / sponsor ID
- 3-2021-0293
- Conditions
- Cervical Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months
| Arm | Type | Receives |
|---|---|---|
| Ultrasound probe sagittal group | Experimental | Procedure: Ultrasound probe sagittal groupA thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe. |
| Ultrasound probe transverse group | Active comparator | Procedure: Ultrasound probe transverse groupA thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound probe sagittal groupPlace 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. | Procedure or surgery | Ultrasound probe sagittal group |
| Ultrasound probe transverse groupPlace 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. | Procedure or surgery | Ultrasound probe transverse group |
Primary outcome
Injectate spread on MRI imge
Time frame: 1 hour after thoracic 2 paravertebral block
Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)
8 secondary outcomes
numeric rating score
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.
perfusion index
Time frame: Before nerve block, after 30 minutes
skin temperature
Time frame: Before nerve block, after 30 minutes
pinprick and cold test
Time frame: Before nerve block, after 30 minutes
Blood pressure in mmHg
Time frame: Before nerve block, after 30 minutes
Pulse rate in /min
Time frame: Before nerve block, after 30 minutes
Presence of adverse events
Time frame: Before nerve block, after 30 minutes
medication quantification scale
Time frame: Before nerve block, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound probe sagittal group and Ultrasound probe transverse group in people with Cervical Spinal Stenosis, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do Hyeong Kim (82-2-2019-4601, BREADFANS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injectate spread on MRI imge (time frame: 1 hour after thoracic 2 paravertebral block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.