Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
1 other identifier
interventional
50
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJune 10, 2016
June 1, 2016
1.6 years
March 25, 2016
June 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Success rate
through the LSB procedure completion (day 0)
Onset time of block (I2)
through the LSB procedure completion (day 0)
The number of needle passes
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
through the LSB procedure completion (day 0)
- +7 more secondary outcomes
Study Arms (2)
Ultrasound with Fluoroscope
EXPERIMENTALThis 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 COMPARATORThis 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 29189275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
June 10, 2016
Record last verified: 2016-06