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

Seoul National University

Status: Unknown

Conditions: Postherpetic Neuralgia; Peripheral Neuropathy; Diabetic Polyneuropathy; Complex Regional Pain Syndrome

Treatments: Procedure: Postprocedure care for LSB; Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):; Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB); Drug: 10 ml of 0.25% levobupivacaine injection for LSB; Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB); Device: Fluoroscope for Lumbar Sympathetic Block (LSB); Device: Ultrasound for Lumbar Sympathetic Block (LSB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02737527

1510-130-716

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ultrasound with Fluoroscope

Experimental group

Description:

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

Treatment:

Drug: 10 ml of 0.25% levobupivacaine injection for LSB

Device: Ultrasound for Lumbar Sympathetic Block (LSB)

Procedure: Postprocedure care for LSB

Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)

Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB)

Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):

Fluoroscope only

Active Comparator group

Description:

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

Treatment:

Drug: 10 ml of 0.25% levobupivacaine injection for LSB

Procedure: Postprocedure care for LSB

Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)

Device: Fluoroscope for Lumbar Sympathetic Block (LSB)

Device: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB)

Procedure: 24G intravenous route for Lumbar Sympathetic Block (LSB):