Complex Regional Pain SyndromeNCT02737527
Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
A study testing 24G intravenous route for Lumbar Sympathetic Block (LSB):, 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) and Ultrasound for Lumbar Sympathetic Block (LSB) in people with Complex Regional Pain Syndrome and Postherpetic Neuralgia, run by Seoul National University at 1 site in South Korea.
Trial summary
This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy
- What is being tested?
- 24G intravenous route for Lumbar Sympathetic Block (LSB):, 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) and Ultrasound for Lumbar Sympathetic Block (LSB)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Nov 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have sympathetically-mediated pain and are supposed to undergo LSB procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (QSART), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.)
- Numeric rating scale (NRS) ≥ 4/10
- Failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment
Who cannot join
- Previous lumbar sympathetic neurolysis
- Bleeding tendency
- Local infection
- Allergy to local anesthetics or contrast media
- Pregnancy
- Severe variation near procedure site-scoliosis, tumor, abdominal aneurysm, etc.
- BMI ≥ 30 kg/m2
- Cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jee Youn . Moon, M.D., 82-10-5299-2036, jymoon0901@gmail.com
Jee Youn Moon, M.D.
About this study
Official title: Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial
This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.
- Conditions
- Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
- Being tested
- 24G intravenous route for Lumbar Sympathetic Block (LSB):, 15-cm Chiba needle for Lumbar Sympathetic Block (LSB), Ultrasound for Lumbar Sympathetic Block (LSB), Fluoroscope for Lumbar Sympathetic Block (LSB), 10 ml of 0.25% levobupivacaine injection for LSB
- Keywords
- ultrasound, lumbar sympathetic block
- Medical subject headings
- Complex Regional Pain Syndromes, Neuralgia, Postherpetic, Diabetic Neuropathies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24G intravenous route for Lumbar Sympathetic Block (LSB):Procedure or surgery
Also called lumbar sympathetic ganglion block (LSGB), lumbar sympathetic chain block
Enrolled subjects enter the operative room with a 24G intravenous route, and then non-invasive blood pressure and pulse oxygen saturation level are continuously monitored during and after the procedure.
15-cm Chiba needle for Lumbar Sympathetic Block (LSB)Device
The skin entry point is infiltrated using 1% lidocaine. A curved 21 G, 15-cm Chiba needle (Cook Inc., Bloomington, IN, USA) is then advanced toward the anterolateral edge of target vertebral body by posterolateral approach in patients with prone position.
Ultrasound for Lumbar Sympathetic Block (LSB)Device
Using Ultrasound, the L3 is identified by locating the lumbosacral junction on a paramedian sagittal scan and then counting cranially. After marking the level of L3 vertebra, the modified transverse scan through lumbar intertransverse space (ITS) is obtained with the transducer positioned 4-6 cm lateral to the mid-line at the L2-L3 intervertebral level. The needle is inserted from a lateral to medial direction using in-plane technique. The needle tip is inserted towards the anterior fascia of the psoas major muscle as close as paravertebral space.
Fluoroscope for Lumbar Sympathetic Block (LSB)Device
Briefly, fluoroscopic guided LSBs are performed at the lower third of the L2 or the upper third of the L3 vertebra. A targeted lumbar vertebral is identified by AP fluoroscopic imaging and the fluoroscopic C-arm is adjusted 25-35° laterally to avoid the transverse process over the needle pathway. After the skin infiltration, the needle is advanced toward the anterolateral edge of the target lumbar vertebra under fluoroscopic guidance using the tunnel vision technique.
10 ml of 0.25% levobupivacaine injection for LSBDrug
After excluding vascular injection with contrast media by a C-arm image intensifier on anteroposterior (AP) and lateral view, 10 ml of 0.25% levobupivacaine is injected through the Chiba needle.
Temperature measurement for Lumbar Sympathetic Block (LSB)Procedure or surgery
Temperature monitoring and measurement: skin-surface temperatures are monitored with small, adhesive thermocouple probes attached bilaterally to the plantar surface of the feet using transparent patches at 1-min intervals for a maximum of 20 min.
Postprocedure care for LSBProcedure or surgery
Adverse events such as genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness), or others are documented during and after the procedure for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound with Fluoroscope | Experimental | This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB Receives: Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):; Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB); Device: Ultrasound for Lumbar Sympathetic Block (LSB); Drug: 10 ml of 0.25% levobupivacaine injection for LSB; Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB); Procedure: Postprocedure care for LSB |
| Fluoroscope only | Active comparator | This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB Receives: Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):; Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB); Device: Fluoroscope for Lumbar Sympathetic Block (LSB); Drug: 10 ml of 0.25% levobupivacaine injection for LSB; Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB); Procedure: Postprocedure care for LSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Procedure time (I1)
U group: the time interval between the contact of the US probe with the patient's skin and the completion of the injection of levobupivacaine F group: the time interval between the first radiographic image and the end of the injection of levobupivacaine
Measured: through the LSB procedure completion (day 0)
Secondary outcomes (12)
Success rate
Definition of successful LSB: temperature rises as high as 2℃ from initial temperature on an ipsilateral sole in 20 min after the injection of levobupivacaine.
Temperatures are measured at 1-min intervals and recorded from the time of administration of levobupivacaine onwards. Assessments are continued for a maximum of 20 min.
Measured: through the LSB procedure completion (day 0)
Onset time of block (I2)
Definition of successful LSB: temperature rises as high as 2℃ from initial temperature on an ipsilateral sole in 20 min after the injection of levobupivacaine.
Temperatures are measured at 1-min intervals and recorded from the time of administration of levobupivacaine onwards. Assessments are continued for a maximum of 20 min.
Measured: through the LSB procedure completion (day 0)
The number of needle passes
In both groups, the initial needle insertion counted as one pass; any subsequent needle advancement that is preceded by a withdrawal of more than 1 cm counts as an additional pass
Measured: through the LSB procedure completion (day 0)
The number of the needle contact to bone during the procedure
Measured: through the LSB procedure completion (day 0)
Spreading pattern of contrast dye during the procedure
Spreading pattern of contrast dye will be measured by 3 patterns (normal/muscular spread pattern/ intravascular spreading).
Measured: through the LSB procedure completion (day 0)
An 11-pointed NRS pain score related to the procedure only
measured twice -1) just after the procedure at OR, and 2) at recovery room just before discharge
Measured: through the LSB procedure completion (day 0)
Any adverse events
genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events
Measured: Up to 72 hours after the procedure
Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
Measured: performs telephone follow-up in 72 hours.
Procedure-related NRS pain score
Measured: performs telephone follow-up in 72 hours.
Changes of dose in analgesics
NSAIDs, paracetamol, and opioids
Measured: performs telephone follow-up in 72 hours.
Any adverse events remained
Measured: performs telephone follow-up in 72 hours.
A 5-pointed Likert satisfaction scale related to the procedure
Measured: performs telephone follow-up in 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
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 Complex Regional Pain SyndromeStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737527
- Sponsor's protocol ID
- 1510-130-716
- Status last verified
- Jun 2016
- First submitted
- 25 Mar 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryu JH, Lee CS, Kim YC, Lee SC, Shankar H, Moon JY. Ultrasound-Assisted Versus Fluoroscopic-Guided Lumbar Sympathetic Ganglion Block: A Prospective and Randomized Study. Anesth Analg. 2018 Apr;126(4):1362-1368. doi: 10.1213/ANE.0000000000002640.
PubMed 29189275
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial
- ClinicalTrials.gov ID
- NCT02737527
- Acronym / sponsor ID
- 1510-130-716
- Conditions
- Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
- Keywords
- ultrasound, lumbar sympathetic block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- 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.
This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound with Fluoroscope | Experimental | Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):, Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB), Device: Ultrasound for Lumbar Sympathetic Block (LSB), Drug: 10 ml of 0.25% levobupivacaine injection for LSB, Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB), Procedure: Postprocedure care for LSBThis group undergoes lumbar sympathetic block using ultrasound and fluoroscope. Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB |
| Fluoroscope only | Active comparator | Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):, Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB), Device: Fluoroscope for Lumbar Sympathetic Block (LSB), Drug: 10 ml of 0.25% levobupivacaine injection for LSB, Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB), Procedure: Postprocedure care for LSBThis group undergoes lumbar sympathetic block using fluoroscope only. Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have sympathetically-mediated pain and are supposed to undergo LSB procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (QSART), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.)
- Numeric rating scale (NRS) ≥ 4/10
- Failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment
Key exclusion criteria (8 listed)
- Previous lumbar sympathetic neurolysis
- Bleeding tendency
- Local infection
- Allergy to local anesthetics or contrast media
- Pregnancy
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 |
|---|---|---|
| 24G intravenous route for Lumbar Sympathetic Block (LSB):Also: lumbar sympathetic ganglion block (LSGB), lumbar sympathetic chain blockEnrolled subjects enter the operative room with a 24G intravenous route, and then non-invasive blood pressure and pulse oxygen saturation level are continuously monitored during and after the procedure. | Procedure or surgery | Fluoroscope only, Ultrasound with Fluoroscope |
| 15-cm Chiba needle for Lumbar Sympathetic Block (LSB)The skin entry point is infiltrated using 1% lidocaine. A curved 21 G, 15-cm Chiba needle (Cook Inc., Bloomington, IN, USA) is then advanced toward the anterolateral edge of target vertebral body by posterolateral approach in patients with prone position. | Device | Fluoroscope only, Ultrasound with Fluoroscope |
| Ultrasound for Lumbar Sympathetic Block (LSB)Using Ultrasound, the L3 is identified by locating the lumbosacral junction on a paramedian sagittal scan and then counting cranially. After marking the level of L3 vertebra, the modified transverse scan through lumbar intertransverse space (ITS) is obtained with the transducer positioned 4-6 cm lateral to the mid-line at the L2-L3 intervertebral level. The needle is inserted from a lateral to medial direction using in-plane technique. The needle tip is inserted towards the anterior fascia of the psoas major muscle as close as paravertebral space. | Device | Ultrasound with Fluoroscope |
| Fluoroscope for Lumbar Sympathetic Block (LSB)Briefly, fluoroscopic guided LSBs are performed at the lower third of the L2 or the upper third of the L3 vertebra. A targeted lumbar vertebral is identified by AP fluoroscopic imaging and the fluoroscopic C-arm is adjusted 25-35° laterally to avoid the transverse process over the needle pathway. After the skin infiltration, the needle is advanced toward the anterolateral edge of the target lumbar vertebra under fluoroscopic guidance using the tunnel vision technique. | Device | Fluoroscope only |
| 10 ml of 0.25% levobupivacaine injection for LSBAfter excluding vascular injection with contrast media by a C-arm image intensifier on anteroposterior (AP) and lateral view, 10 ml of 0.25% levobupivacaine is injected through the Chiba needle. | Drug | Fluoroscope only, Ultrasound with Fluoroscope |
| Temperature measurement for Lumbar Sympathetic Block (LSB)Temperature monitoring and measurement: skin-surface temperatures are monitored with small, adhesive thermocouple probes attached bilaterally to the plantar surface of the feet using transparent patches at 1-min intervals for a maximum of 20 min. | Procedure or surgery | Fluoroscope only, Ultrasound with Fluoroscope |
| Postprocedure care for LSBAdverse events such as genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness), or others are documented during and after the procedure for 30 min. | Procedure or surgery | Fluoroscope only, Ultrasound with Fluoroscope |
Primary outcome
Difference in Procedure time (I1)
Time frame: through the LSB procedure completion (day 0)
U group: the time interval between the contact of the US probe with the patient's skin and the completion of the injection of levobupivacaine F group: the time interval between the first radiographic image and the end of the injection of levobupivacaine
12 secondary outcomes
Success rate
Time frame: through the LSB procedure completion (day 0)
Onset time of block (I2)
Time frame: through the LSB procedure completion (day 0)
The number of needle passes
Time frame: through the LSB procedure completion (day 0)
The number of the needle contact to bone during the procedure
Time frame: through the LSB procedure completion (day 0)
Spreading pattern of contrast dye during the procedure
Time frame: through the LSB procedure completion (day 0)
An 11-pointed NRS pain score related to the procedure only
Time frame: through the LSB procedure completion (day 0)
Any adverse events
Time frame: Up to 72 hours after the procedure
Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
Time frame: performs telephone follow-up in 72 hours.
Procedure-related NRS pain score
Time frame: performs telephone follow-up in 72 hours.
Changes of dose in analgesics
Time frame: performs telephone follow-up in 72 hours.
Any adverse events remained
Time frame: performs telephone follow-up in 72 hours.
A 5-pointed Likert satisfaction scale related to the procedure
Time frame: performs telephone follow-up in 72 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 29189275Ryu JH, Lee CS, Kim YC, Lee SC, Shankar H, Moon JY. Ultrasound-Assisted Versus Fluoroscopic-Guided Lumbar Sympathetic Ganglion Block: A Prospective and Randomized Study. Anesth Analg. 2018 Apr;126(4):1362-1368. doi: 10.1213/ANE.0000000000002640.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24G intravenous route for Lumbar Sympathetic Block (LSB):, 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) and Ultrasound for Lumbar Sympathetic Block (LSB) in people with Complex Regional Pain Syndrome and Postherpetic Neuralgia, run by Seoul National 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 3 inclusion and 8 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 10 Jun 2016. 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 Jee Youn Moon, MD, PhD (82-10-5299-2036, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Procedure time (I1) (time frame: through the LSB procedure completion (day 0)). 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 NCT02737527, 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 10 Jun 2016.