Clinical trial NCT02737527: Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
Official title: Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Regional Pain Syndrome
Postherpetic Neuralgia
Diabetic Polyneuropathy
Peripheral Neuropathy
Keywords: ultrasound
lumbar sympathetic block
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Procedure time (I1)
timeFrame: through the LSB procedure completion (day 0)
Secondary outcomes:
measure: Success rate
timeFrame: through the LSB procedure completion (day 0)
measure: Onset time of block (I2)
timeFrame: through the LSB procedure completion (day 0)
measure: The number of needle passes
timeFrame: through the LSB procedure completion (day 0)
measure: The number of the needle contact to bone during the procedure
timeFrame: through the LSB procedure completion (day 0)
measure: Spreading pattern of contrast dye during the procedure
timeFrame: through the LSB procedure completion (day 0)
measure: An 11-pointed NRS pain score related to the procedure only
timeFrame: through the LSB procedure completion (day 0)
measure: Any adverse events
timeFrame: Up to 72 hours after the procedure
measure: Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
timeFrame: performs telephone follow-up in 72 hours.
measure: Procedure-related NRS pain score
timeFrame: performs telephone follow-up in 72 hours.
measure: Changes of dose in analgesics
timeFrame: performs telephone follow-up in 72 hours.
measure: Any adverse events remained
timeFrame: performs telephone follow-up in 72 hours.
measure: A 5-pointed Likert satisfaction scale related to the procedure
timeFrame: performs telephone follow-up in 72 hours.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: 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.