Pain, ChronicNCT05723419
Prediction of Clinical Outcome in Axillary Block
An observational study of Pain, Chronic, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- axillary block using 5 ml local anesthetics
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2023to 30 Nov 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who visit the pain clinic
Who may be able to join
- Cervical foraminal stenosis
- Cervical central stenosis
- Cervical disc herniation
- Cervical spondylolisthesis
Who cannot join
- Infection
- pregnancy
- allergy to local anesthetic agents
- previous cervical spine surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ji Hoon Park
Daegu, 42601
Ji Hoon Park, +82532587760, cmjihoon@gmail.com
J Hee Hong, 82-53-258-7767, swon13@daum.net
About this study
Official title: Perfusion Index Value in Predicting the Clinical Outcome of Axillary Block
The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy
Read the detailed description
The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.
Recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy.
The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.
There have been no studies demonstrating any predictive value of PI in axillary block for the relief of cervical radiulopathy
- Conditions
- Pain, Chronic
- Being tested
- axillary block using 5 ml local anesthetics
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary block using 5 ml local anestheticsProcedure or surgery
ultrasoud guided axillary block
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index changes among 4 time periods
Perfusion index changes among 4 time periods
Measured: baseline, 10 minutes, 20 minutes, 30 minutes after axillary block
Number of patients showing numerical rating scale reduction more than 50%
Number of patients showing numerical rating scale reduction more than 50%
Measured: 1 month after axillary block
Number of patients showing numerical rating scale reduction less than 50%
Number of patients showing numerical rating scale reduction less than 50%
Measured: 1 month after axillary block
Number of patients showing no reduction in numerical rating scale
Number of patients showing no reduction in numerical rating scale
Measured: 1 month after axillary block
Neck disability index changes between 2 time periods
Neck disability index changes between 2 time periods
Measured: baseline, 1 month after axillary block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start13 Feb 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723419
- Sponsor's protocol ID
- 20201-025-04
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index Value in Predicting the Clinical Outcome of Axillary Block
- ClinicalTrials.gov ID
- NCT05723419
- Acronym / sponsor ID
- 20201-025-04
- Conditions
- Pain, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 10 Feb 2023 (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 primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy
Detailed description
The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.
Recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy.
The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.
There have been no studies demonstrating any predictive value of PI in axillary block for the relief of cervical radiulopathy
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who visit the pain clinic
Key inclusion criteria (4 listed)
- Cervical foraminal stenosis
- Cervical central stenosis
- Cervical disc herniation
- Cervical spondylolisthesis
Key exclusion criteria (4 listed)
- Infection
- pregnancy
- allergy to local anesthetic agents
- previous cervical spine surgery
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 |
|---|---|---|
| axillary block using 5 ml local anestheticsultrasoud guided axillary block | Procedure or surgery | – |
Primary outcome
Perfusion index changes among 4 time periods
Time frame: baseline, 10 minutes, 20 minutes, 30 minutes after axillary block
Perfusion index changes among 4 time periods
Number of patients showing numerical rating scale reduction more than 50%
Time frame: 1 month after axillary block
Number of patients showing numerical rating scale reduction more than 50%
Number of patients showing numerical rating scale reduction less than 50%
Time frame: 1 month after axillary block
Number of patients showing numerical rating scale reduction less than 50%
Number of patients showing no reduction in numerical rating scale
Time frame: 1 month after axillary block
Number of patients showing no reduction in numerical rating scale
Neck disability index changes between 2 time periods
Time frame: baseline, 1 month after axillary block
Neck disability index changes between 2 time periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- 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?
An observational study of Pain, Chronic, run by Keimyung University Dongsan Medical Center 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 4 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 15 Feb 2023. 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 Ji H Hong (01046794343, swon13@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index changes among 4 time periods (time frame: baseline, 10 minutes, 20 minutes, 30 minutes after axillary block). The study lists 5 primary outcomes in all. 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 15 Feb 2023.