BlockNCT06963424
Pain Relief and and Peripheral Perfusion Index During Erector Spinae Block
A study testing Erector Spinae Plane Block in people with Block and Block, Fascicular, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The primary endpoint of this study is to compare the pain relief and peripheral perfusion index when local anesthetics injected in different final target area during lumbar erector spinae block The secondary endpoint of this study is to compare the procedure related pain Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Block, Block, Fascicular, Spinae
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2025to 30 Dec 2025
- 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
- numerical rating scale > 4
- back pain functional scale < 45
- duration of pain > 1 mon
- patients who can fully understand all items described in back pain functional scale
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief and Peripheral Perfusion Index When Local Anesthetics Injected in Different Final Target Area During Lumbar Erector Spinae Block
The primary endpoint of this study is to compare the pain relief and peripheral perfusion index when local anesthetics injected in different final target area during lumbar erector spinae block The secondary endpoint of this study is to compare the procedure related pain
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 final target area of ESPB of cervical, thoarcic, and lumbar regiona is transverse process. Once the needle contact the tip of the transverse process, local anesthetics is injected subsequentely. However, contacting the bony structure with the needle can generage procedure related pain. If ESPB can be performed without touching the transverse process, the satisfaction of patient would be increased. Actually, intertransverse ligament, which is visibe by ultrasound, is present between transverse process. Therefore, if local anesthetics is injected after targeting intertransverse ligament, same effect of pain relief with tarting of transverse process of ESPB is uncertain
- Conditions
- Block, Block, Fascicular, Spinae
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Bites and Stings, Bundle-Branch Block
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
lumbar erectro spinae block
| Study group | Role | What they receive |
|---|---|---|
| intertransverse ligagment group | Experimental | lumbar ESPB was performed with final target at intertransverse ligament Receives: Procedure: Erector Spinae Plane Block |
| transverse process group | Placebo comparator | lumbar ESPB was performed with final target at transverse process 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
minimum (1) and maximum value (10), lower score means better treatment outcome
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block
Secondary outcomes (1)
back pain functional scale among 3 times period
minimum (0) and maximum value (60), higher score means better treatment outcome
Measured: Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start13 May 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlockStudies 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
- 90 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963424
- Sponsor's protocol ID
- 2025-02-028
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief and Peripheral Perfusion Index When Local Anesthetics Injected in Different Final Target Area During Lumbar Erector Spinae Block
- ClinicalTrials.gov ID
- NCT06963424
- Acronym / sponsor ID
- 2025-02-028
- Conditions
- Block, Block, Fascicular, Spinae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 9 May 2025 (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 is to compare the pain relief and peripheral perfusion index when local anesthetics injected in different final target area during lumbar erector spinae block The secondary endpoint of this study is to compare the procedure related pain
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 final target area of ESPB of cervical, thoarcic, and lumbar regiona is transverse process. Once the needle contact the tip of the transverse process, local anesthetics is injected subsequentely. However, contacting the bony structure with the needle can generage procedure related pain. If ESPB can be performed without touching the transverse process, the satisfaction of patient would be increased. Actually, intertransverse ligament, which is visibe by ultrasound, is present between transverse process. Therefore, if local anesthetics is injected after targeting intertransverse ligament, same effect of pain relief with tarting of transverse process of ESPB is uncertain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intertransverse ligagment group | Experimental | Procedure: Erector Spinae Plane Blocklumbar ESPB was performed with final target at intertransverse ligament |
| transverse process group | Placebo comparator | Procedure: Erector Spinae Plane Blocklumbar ESPB was performed with final target at transverse process |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- lumbar disc herniation
- lumbar foraminal stenosis
- lumbar central stenosis
- lumbar spondylolisthesis
- numerical rating scale > 4
Key exclusion criteria (6 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 Blocklumbar erectro spinae block | Procedure or surgery | intertransverse ligagment group, transverse process group |
Primary outcome
Numerical rating scale changes among 5 times period
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block
minimum (1) and maximum value (10), lower score means better treatment outcome
1 secondary outcome
back pain functional scale among 3 times period
Time frame: Baseline, 4 weeks, 8 weeks after the completion of erector spine 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 9 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Block and Block, Fascicular, 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 8 inclusion and 6 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 9 Jan 2026. 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. Some participants in this study may receive a placebo. 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, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine 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 9 Jan 2026.