PainNCT05280847
Analysis of Injectate Spread During Erector Spinae Block
A study testing Erector spinae plane block in people with Pain and Cervical, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
Trial summary
The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB Read more about this study
- Who is it for?
- Ages 20 to 80 years
- 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
- 159 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Feb 2022to 30 Oct 2022
- 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
2 sites in 1 country.
About this study
Official title: Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics
The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB
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. 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.
- Being tested
- Erector spinae plane block
- Keywords
- Pain, Cervical, Spread
- Medical subject headings
- 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
Also called ESP
fascial plane injection using ultrasound and fluoroscopic guidance
| Study group | Role | What they receive |
|---|---|---|
| 10 ml ESP group | Experimental | ESP group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy Receives: Procedure: Erector spinae plane block |
| 20 ml ESP group | Experimental | ESP group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
spread level in the cranio-caudal direction
fluoroscopic contrast medium spread level in the cranio-caudal direction
Measured: baseline, 1 minutes after erector spinae plane block
Secondary outcomes (4)
Number of participant showing epidural spread
Number of participant showing epidural spread by analysis of fluoroscopic image
Measured: baseline, 1 minute after erector spinae plane block
Number of participant showing intercostal spread
Number of participant showing intercostal spread by analysis of fluoroscopic image
Measured: baseline, 1 minute after erector spinae plane block
Number of participant showing paravertebral spread
Number of participant showing paravertebral spread by analysis of fluorosocpic image
Measured: baseline, 1 minute after erector spinae plane block
Number of participant showing intravascular spread
Number of participants showing intravascular spread by analysis of fluoroscopic image
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 posted15 Mar 2022
- Study start21 Feb 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 159 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, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280847
- Sponsor's protocol ID
- Keimyung University
- Status last verified
- Dec 2022
- First submitted
- 10 Feb 2022
- Last updated
- 20 Dec 2022
- 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 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics
- ClinicalTrials.gov ID
- NCT05280847
- Acronym / sponsor ID
- Keimyung University
- Keywords
- Pain, Cervical, Spread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 15 Mar 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 purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB
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. 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 | Experimental | Procedure: Erector spinae plane blockESP group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy |
| 20 ml ESP group | Experimental | Procedure: Erector spinae plane blockESP group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy |
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 blockAlso: ESPfascial plane injection using ultrasound and fluoroscopic guidance | Procedure or surgery | 10 ml ESP group, 20 ml ESP group |
Primary outcome
spread level in the cranio-caudal direction
Time frame: baseline, 1 minutes after erector spinae plane block
fluoroscopic contrast medium spread level in the cranio-caudal direction
4 secondary outcomes
Number of participant showing epidural spread
Time frame: baseline, 1 minute after erector spinae plane block
Number of participant showing intercostal spread
Time frame: baseline, 1 minute after erector spinae plane block
Number of participant showing paravertebral spread
Time frame: baseline, 1 minute after erector spinae plane block
Number of participant showing intravascular spread
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 20 Dec 2022.
- 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 principal investigator
Keimyung University
2 sites 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 and Cervical, run by Keimyung University Dongsan Medical Center at 2 sites 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
spread level in the cranio-caudal direction (time frame: baseline, 1 minutes after erector spinae plane 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 20 Dec 2022.