Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial

Conditions
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Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy

Intervention / Treatment
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* 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)
* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound with Fluoroscope<br>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 | Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):<br>* 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.<br>* Other names: lumbar sympathetic chain block;Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Device: Ultrasound for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Drug: 10 ml of 0.25% levobupivacaine injection for LSB<br>* 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.<br>Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Procedure: Postprocedure care for LSB<br>* 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.<br>|
| Active Comparator: Fluoroscope only<br>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 | Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):<br>* 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.<br>* Other names: lumbar sympathetic chain block;Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Device: Fluoroscope for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Drug: 10 ml of 0.25% levobupivacaine injection for LSB<br>* 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.<br>Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)<br>* 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.<br>Procedure: Postprocedure care for LSB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, lumbar sympathetic block