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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24G intravenous route for Lumbar Sympathetic Block (LSB): | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through the LSB procedure completion (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through the LSB procedure completion (day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jee Youn Moon, MD, PhD | Contact | 82-10-5299-2036 | jymoon0901@gmail.com | |
| Chang Soon Lee, MD | Contact | 82-2-2072-0881 | iparid@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29189275 | Derived | 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. |
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|
| 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 LSB | Drug | 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 | 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 LSB | Procedure | 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. |
|
| 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. | 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 | through the LSB procedure completion (day 0) |
| The number of the needle contact to bone during the procedure | 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). | 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 | through the LSB procedure completion (day 0) |
| Any adverse events | genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events | Up to 72 hours after the procedure |
| Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain | performs telephone follow-up in 72 hours. |
| Procedure-related NRS pain score | performs telephone follow-up in 72 hours. |
| Changes of dose in analgesics | NSAIDs, paracetamol, and opioids | performs telephone follow-up in 72 hours. |
| Any adverse events remained | performs telephone follow-up in 72 hours. |
| A 5-pointed Likert satisfaction scale related to the procedure | performs telephone follow-up in 72 hours. |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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