An interventional study of 24G intravenous route for Lumbar Sympathetic Block (LSB): and 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) in Complex Regional Pain Syndrome, Postherpetic Neuralgia and Diabetic Polyneuropathy, sponsored by Seoul National University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-06-10.
Sponsored by Seoul National University · Not applicable, Interventional, and Treatment
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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This study's planned enrollment of 50 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
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Exclusion Criteria:
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): · 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
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): · 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
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.
Also known as: lumbar sympathetic ganglion block (LSGB), lumbar sympathetic chain block
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.
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.
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.
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 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.
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.
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
Time frame: through the LSB procedure completion (day 0)
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.
Time frame: 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.
Time frame: 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
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
Spreading pattern of contrast dye will be measured by 3 patterns (normal/muscular spread pattern/ intravascular spreading).
Time frame: 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
Time frame: through the LSB procedure completion (day 0)
Any adverse events
genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other 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
NSAIDs, paracetamol, and opioids
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.
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Seoul National University