ClinicalTrials.Veeva

Menu

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

S

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)

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):

Trial contacts and locations

1

Loading...

Central trial contact

Chang Soon Lee, MD; Jee Youn Moon, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems