Pain, ChronicNCT05723367
Prediction of Clinical Outcome in Lumbar ESPB
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?
- lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20ml
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 85 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit the pain clinic
Who may be able to join
- Lumbar foraminal stenosis
- Lumbar central stenosis
- Lumbar disc herniation
- Lumbar spondylolisthesis
Who cannot join
- Infection
- Pregnancy
- allergy to local anesthetic agnets
- Previous lumbar 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 Lumbar ESPB
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 erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. 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 predictive value of PI in lumbar ESPB ESPB for the relief of low back pain or leg pain due to lumbar disc herniation or stenosis.
- Conditions
- Pain, Chronic
- Being tested
- lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20ml
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20mlProcedure or surgery
ultrasound guided fascial plane injection
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 after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane 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 erector spinae plane 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 erector spinae plane 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 erector spinae plane block
Back pain functional scale between 2 time periods
Back pain functional scale between 2 time periods
Measured: baseline, 1 month after erector spinae plane 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 85 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
- NCT05723367
- Sponsor's protocol ID
- 2023-01-025-03
- 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
Publications
Hong JH, Park JH, Park KB. Predictors of a Favorable Response to Erector Spinae Plane Block for Lumbosacral Radiculopathy. Pain Physician. 2024 Jan;27(1):89-95.
PubMed 38285039
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 Lumbar ESPB
- ClinicalTrials.gov ID
- NCT05723367
- Acronym / sponsor ID
- 2023-01-025-03
- Conditions
- Pain, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 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 erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. 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 predictive value of PI in lumbar ESPB ESPB for the relief of low back pain or leg pain due to lumbar disc herniation or stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit the pain clinic
Key inclusion criteria (4 listed)
- Lumbar foraminal stenosis
- Lumbar central stenosis
- Lumbar disc herniation
- Lumbar spondylolisthesis
Key exclusion criteria (4 listed)
- Infection
- Pregnancy
- allergy to local anesthetic agnets
- Previous lumbar 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 |
|---|---|---|
| lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20mlultrasound guided fascial plane injection | Procedure or surgery | – |
Primary outcome
Perfusion index changes among 4 time periods
Time frame: baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block
Perfusion index changes among 4 time periods
Number of patients showing numerical rating scale reduction more than 50%
Time frame: 1 month after erector spinae plane 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 erector spinae plane 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 erector spinae plane block
Number of patients showing no reduction in numerical rating scale
Back pain functional scale between 2 time periods
Time frame: baseline, 1 month after erector spinae plane block
Back pain functional scale 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.
- Derived from this study: PubMed 38285039Hong JH, Park JH, Park KB. Predictors of a Favorable Response to Erector Spinae Plane Block for Lumbosacral Radiculopathy. Pain Physician. 2024 Jan;27(1):89-95.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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 after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane 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?
On the ClinicalTrials.gov record for NCT05723367, which also lists 1 linked publication.
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.