Pain, ChronicNCT05487339
Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane 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 eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed. 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
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2022to 24 Feb 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
- lumbar disc herniation
- lumbar foraminal stenosis
- lumbar central stenosis
- lumbar spondylolisthesis
- severe level of spine at L3-4
- numerical rating scale > 4
Show all 9Show fewer
- back pain functional scale < 45
- duration of pain > 1 month
- patients who can fully understand all items described in BPFS
Who cannot join
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Prior history of lumbar spine surgery
- No previous lumbar MRI or CT
- Patients with coagulation abnormality
- Incorrect level of ESPB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pain Relief and Spread Level in Upper and Lower Lumbar Erector Spinae Plane Block
The primary endpoint of this study was to identify if eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.
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. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required
- Conditions
- Pain, Chronic
- Being tested
- Erector spinae plane block
- Keywords
- Pain, Lumbar, 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 fluoroscopy device
| Study group | Role | What they receive |
|---|---|---|
| upper lumbar ESPB group | Active comparator | Group where ESPB is performed at L2 with local anesthetic mixture 20 ml Receives: Procedure: Erector spinae plane block |
| lower lumbar ESPB group | Active comparator | Group where ESPB is performed at L4 with local anesthetic mixture 20 ml 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 ESPB among 5 times period
Measured: baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB
back pain function scale changes among 2 times period
back pain function scale changes after ESPB among 2 times period
Measured: baseline, 4 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 ESPB
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 completion24 Feb 2023
- Study completion24 Feb 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
- 84 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
- NCT05487339
- Sponsor's protocol ID
- Keimyung Medical School
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2022
- Last updated
- 27 Feb 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Relief and Spread Level in Upper and Lower Lumbar Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT05487339
- Acronym / sponsor ID
- Keimyung Medical School
- Conditions
- Pain, Chronic
- Keywords
- Pain, Lumbar, Spread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 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 eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.
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. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper lumbar ESPB group | Active comparator | Procedure: Erector spinae plane blockGroup where ESPB is performed at L2 with local anesthetic mixture 20 ml |
| lower lumbar ESPB group | Active comparator | Procedure: Erector spinae plane blockGroup where ESPB is performed at L4 with local anesthetic mixture 20 ml |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- lumbar disc herniation
- lumbar foraminal stenosis
- lumbar central stenosis
- lumbar spondylolisthesis
- severe level of spine at L3-4
Key exclusion criteria (7 listed)
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Prior history of lumbar spine surgery
- No previous lumbar MRI or CT
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 fluoroscopy device | Procedure or surgery | lower lumbar ESPB group, upper lumbar ESPB 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
numerical rating scale changes after ESPB among 5 times period
back pain function scale changes among 2 times period
Time frame: baseline, 4 weeks after ESPB
back pain function scale changes after ESPB among 2 times period
1 secondary outcome
spread level in the cranio-caudal direction
Time frame: baseline, 1 minute after ESPB
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 27 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.
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 9 inclusion and 7 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 27 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?
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). 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 27 Feb 2023.