Lumbar Radiculopathy Due to Spinal Nerve CompressionNCT03308136
The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
A study testing 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer., 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. and 1% Lidocaine in people with Lumbar Radiculopathy Due to Spinal Nerve Compression, run by Yonsei University at 1 site in South Korea.
Trial summary
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbar Radiculopathy Due to Spinal Nerve Compression
- What is being tested?
- 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer., 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. and 1% Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2017to 28 Feb 2018
- 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
- 1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.
Who cannot join
- Blood clotting disorder
- Infection around the site
- Contrast agent allergy
- Uncontrolled cardiovascular, cerebrovascular, kidney disease
- Past history of spinal surgery (ex, spinal fusion)
- If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
- Patients taking narcotic analgesics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
Seoul, 03722
About this study
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.
Read the detailed description
- A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
- This study is single-blind because it is not possible to blind the practitioner performing the injection.
- Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the muscle anesthesia group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
- After the procedure, a resident who does not know of this study records the patient's pain and discomfort. and on follow-up visits, post injection site pain is checked.
- Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner
- Being tested
- 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer., 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway., 1% Lidocaine
- Keywords
- epidural steroid injection, procedural pain, local Anesthetic Injection
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.Procedure or surgery
- In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.Procedure or surgery
- In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
1% LidocaineDrug
1% Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous anesthesia group (group A) | Experimental | Not described Receives: Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.; Drug: 1% Lidocaine |
| muscle anesthesia group (group B) | Active comparator | Not described Receives: Procedure: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.; Drug: 1% Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain score (NRS)
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
Measured: Immediately after the procedure
Secondary outcomes (1)
At the next outpatient visit, whether the injection site pain(Yes) or not(No)
At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start16 Oct 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Radiculopathy Due to Spinal Nerve CompressionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308136
- Sponsor's protocol ID
- 4-2017-0683
- Status last verified
- Jan 2019
- First submitted
- 20 Sep 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek IC, Choi SY, Suh J, Kim SH. The Influence of Local Anesthesia Depth on Procedural Pain During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Apr;98(4):253-257. doi: 10.1097/PHM.0000000000001032.
PubMed 30153126
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
- ClinicalTrials.gov ID
- NCT03308136
- Acronym / sponsor ID
- 4-2017-0683
- Keywords
- epidural steroid injection, procedural pain, local Anesthetic Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Oct 2017 (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.
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.
Detailed description
- A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
- This study is single-blind because it is not possible to blind the practitioner performing the injection.
- Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the muscle anesthesia group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
- After the procedure, a resident who does not know of this study records the patient's pain and discomfort. and on follow-up visits, post injection site pain is checked.
- Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
| Arm | Type | Receives |
|---|---|---|
| subcutaneous anesthesia group (group A) | Experimental | Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer., Drug: 1% Lidocaine |
| muscle anesthesia group (group B) | Active comparator | Procedure: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway., Drug: 1% Lidocaine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.
Key exclusion criteria (7 listed)
- Blood clotting disorder
- Infection around the site
- Contrast agent allergy
- Uncontrolled cardiovascular, cerebrovascular, kidney disease
- Past history of spinal surgery (ex, spinal fusion)
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 |
|---|---|---|
| 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer. | Procedure or surgery | subcutaneous anesthesia group (group A) |
| 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. | Procedure or surgery | muscle anesthesia group (group B) |
| 1% Lidocaine1% Lidocaine | Drug | muscle anesthesia group (group B), subcutaneous anesthesia group (group A) |
Primary outcome
Procedural Pain score (NRS)
Time frame: Immediately after the procedure
Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)
1 secondary outcome
At the next outpatient visit, whether the injection site pain(Yes) or not(No)
Time frame: 2 weeks
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 11 Jan 2019.
- Derived from this study: PubMed 30153126Baek IC, Choi SY, Suh J, Kim SH. The Influence of Local Anesthesia Depth on Procedural Pain During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Apr;98(4):253-257. doi: 10.1097/PHM.0000000000001032.
- Individual participant dataSharing planned: No
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 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer., 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. and 1% Lidocaine in people with Lumbar Radiculopathy Due to Spinal Nerve Compression, run by Yonsei University 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 1 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 11 Jan 2019. 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?
Procedural Pain score (NRS) (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308136, which also lists 1 linked publication.
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 11 Jan 2019.