Pain, ChronicNCT05487326
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
A study testing Erector spinae plane block and cervical epidural injection 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 whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection 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 and cervical epidural injection
- 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
- 7 Aug 2022to 30 Apr 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 spinal stenosis
- cervical intervertebral disc herniation
- cervical facet arthropathy
- cervical foraminal stenosis
Who cannot join
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Patients with coagulation abnormality
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hong ji HEE
Daegu, 42601
J Hee Hong, 82-53-258-7767, swon13@daum.net
About this study
The primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection
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. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.
- Conditions
- Pain, Chronic
- Being tested
- Erector spinae plane block, cervical epidural injection
- Keywords
- Pain, lumbar
- 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 ultrasound guidance
cervical epidural injectionProcedure or surgery
cervical epidural injection by fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| high thoracic ESPB group | Active comparator | Group where ESPB is performed at T2 with local anesthetic mixture 20 ml Receives: Procedure: Erector spinae plane block |
| cervical epidural group | Active comparator | Group where cervical epidural injection is performed at C6-7 or C7-T1 level Receives: Procedure: cervical epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of numerical rating scale
Changes of 11-point numerical rating scale (0-10)
Measured: baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection
Secondary outcomes (1)
Changes of neck disability index
Changes of back pain funtional scale
Measured: baseline, 8 wks after injection
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 start7 Aug 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 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
- 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 (estimated)
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
- NCT05487326
- Sponsor's protocol ID
- 2022-01-026-03
- Status last verified
- Apr 2023
- First submitted
- 1 Aug 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
- ClinicalTrials.gov ID
- NCT05487326
- Acronym / sponsor ID
- 2022-01-026-03
- Conditions
- Pain, Chronic
- Keywords
- Pain, lumbar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- 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 whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection
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. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high thoracic ESPB group | Active comparator | Procedure: Erector spinae plane blockGroup where ESPB is performed at T2 with local anesthetic mixture 20 ml |
| cervical epidural group | Active comparator | Procedure: cervical epidural injectionGroup where cervical epidural injection is performed at C6-7 or C7-T1 level |
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 spinal stenosis
- cervical intervertebral disc herniation
- cervical facet arthropathy
- cervical foraminal stenosis
Key exclusion criteria (4 listed)
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Patients with 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 ultrasound guidance | Procedure or surgery | high thoracic ESPB group |
| cervical epidural injectioncervical epidural injection by fluoroscopy | Procedure or surgery | cervical epidural group |
Primary outcome
Changes of numerical rating scale
Time frame: baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection
Changes of 11-point numerical rating scale (0-10)
1 secondary outcome
Changes of neck disability index
Time frame: baseline, 8 wks after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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 and cervical epidural injection 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: status not confirmed, as of the sponsor's last update on 5 Apr 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, Ph.D (01046794343, swon13@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of numerical rating scale (time frame: baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection). 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 5 Apr 2023.