Pain, ChronicNCT05487313
Pain Relief After High Thoracic Eretor Spinae Block
A study testing Erector spinae plane block in people with 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 if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level. 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?
- Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2022to 21 Mar 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cervical facet joint arthrosis
- cervical foraminal stenosis
- cervical herniated intervertebral disc
- myofascial pain syndrome of upper back muscle
Who cannot join
- Allergy to local anesthetics or contrast medium
- pregnancy
- prior history of cervical spine surgery
- coagulation abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pain Relief During High Thoracic Erector Spinae Plane Block Using Different Volumes of Local Anesthetics
The primary endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.
Read the detailed description
The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base (1,10). The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions.
Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side.
The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.
- Conditions
- Pain, Chronic
- Being tested
- Erector spinae plane block
- Keywords
- Pain, Cervical, Spread
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
fascial plane injection guided by fluoroscopic device after ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| 10 ml ESP group | Active comparator | ESP group using 10 ml mixture of local anesthetics and contrast medium Receives: Procedure: Erector spinae plane block |
| 20 ml ESP group | Active comparator | ESP group using 20 ml mixture of local anesthetics and contrast medium Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale changes among 5 times period
numerical rating scale changes after T2 ESPB among 5 times period
Measured: baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB
Neck disability scale changes
Neck disability scale changes after T2 ESPB among 2 times period
Measured: baseline, 8 weeks after ESPB
Secondary outcomes (1)
spread level in the cranio-caudal direction
fluoroscopic contrast medium spread level in the cranio-caudal direction
Measured: baseline, 1 minute 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 posted4 Aug 2022
- Study start12 Aug 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
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
- Investigators
- Ji H Hong, Ph.D, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487313
- Sponsor's protocol ID
- 2022-01-026-02
- Status last verified
- Mar 2023
- First submitted
- 1 Aug 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Relief During High Thoracic Erector Spinae Plane Block Using Different Volumes of Local Anesthetics
- ClinicalTrials.gov ID
- NCT05487313
- Acronym / sponsor ID
- 2022-01-026-02
- Conditions
- Pain, Chronic
- Keywords
- Pain, Cervical, Spread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 4 Aug 2022 (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 if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.
Detailed description
The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base (1,10). The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions.
Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side.
The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 ml ESP group | Active comparator | Procedure: Erector spinae plane blockESP group using 10 ml mixture of local anesthetics and contrast medium |
| 20 ml ESP group | Active comparator | Procedure: Erector spinae plane blockESP group using 20 ml mixture of local anesthetics and contrast medium |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cervical facet joint arthrosis
- cervical foraminal stenosis
- cervical herniated intervertebral disc
- myofascial pain syndrome of upper back muscle
Key exclusion criteria (4 listed)
- Allergy to local anesthetics or contrast medium
- pregnancy
- prior history of cervical spine surgery
- coagulation abnormality
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 |
|---|---|---|
| Erector spinae plane blockfascial plane injection guided by fluoroscopic device after ultrasound guidance | Procedure or surgery | 10 ml ESP group, 20 ml ESP group |
Primary outcome
numerical rating scale changes among 5 times period
Time frame: baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB
numerical rating scale changes after T2 ESPB among 5 times period
Neck disability scale changes
Time frame: baseline, 8 weeks after ESPB
Neck disability scale changes after T2 ESPB among 2 times period
1 secondary outcome
spread level in the cranio-caudal direction
Time frame: baseline, 1 minute after erector spinae plane block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
Ji H Hong, Ph.D principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with 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: finished, as of the sponsor's last update on 30 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale changes among 5 times period (time frame: baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB). The study lists 2 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 30 Mar 2023.