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

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ClinicalTrials.gov Identifier: NCT02737527
Recruitment Status : Unknown
Verified June 2016 by Jeeyoun Moon, Seoul National University.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Postherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy 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) 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial
Study Start Date : April 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound with Fluoroscope

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):
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.
Other Names:
  • lumbar sympathetic ganglion block (LSGB)
  • lumbar sympathetic chain block

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

Device: Ultrasound for Lumbar Sympathetic Block (LSB)
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.

Drug: 10 ml of 0.25% levobupivacaine injection for LSB
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.

Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)
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.

Procedure: Postprocedure care for LSB
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.

Active Comparator: Fluoroscope only

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):
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.
Other Names:
  • lumbar sympathetic ganglion block (LSGB)
  • lumbar sympathetic chain block

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

Device: Fluoroscope for Lumbar Sympathetic Block (LSB)
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.

Drug: 10 ml of 0.25% levobupivacaine injection for LSB
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.

Procedure: Temperature measurement for Lumbar Sympathetic Block (LSB)
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.

Procedure: Postprocedure care for LSB
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.




Primary Outcome Measures :
  1. Difference in Procedure time (I1) [ Time Frame: through the LSB procedure completion (day 0) ]
    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


Secondary Outcome Measures :
  1. Success rate [ Time Frame: through the LSB procedure completion (day 0) ]

    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.


  2. Onset time of block (I2) [ Time Frame: through the LSB procedure completion (day 0) ]

    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.


  3. The number of needle passes [ Time Frame: through the LSB procedure completion (day 0) ]
    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

  4. The number of the needle contact to bone during the procedure [ Time Frame: through the LSB procedure completion (day 0) ]
  5. Spreading pattern of contrast dye during the procedure [ Time Frame: through the LSB procedure completion (day 0) ]
    Spreading pattern of contrast dye will be measured by 3 patterns (normal/muscular spread pattern/ intravascular spreading).

  6. An 11-pointed NRS pain score related to the procedure only [ Time Frame: through the LSB procedure completion (day 0) ]
    measured twice -1) just after the procedure at OR, and 2) at recovery room just before discharge

  7. Any adverse events [ Time Frame: Up to 72 hours after the procedure ]
    genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events

  8. Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain [ Time Frame: performs telephone follow-up in 72 hours. ]
  9. Procedure-related NRS pain score [ Time Frame: performs telephone follow-up in 72 hours. ]
  10. Changes of dose in analgesics [ Time Frame: performs telephone follow-up in 72 hours. ]
    NSAIDs, paracetamol, and opioids

  11. Any adverse events remained [ Time Frame: performs telephone follow-up in 72 hours. ]
  12. A 5-pointed Likert satisfaction scale related to the procedure [ Time Frame: performs telephone follow-up in 72 hours. ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737527


Contacts
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Contact: Jee Youn Moon, MD, PhD 82-10-5299-2036 jymoon0901@gmail.com
Contact: Chang Soon Lee, MD 82-2-2072-0881 iparid@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jee Youn . Moon, M.D.    82-10-5299-2036    jymoon0901@gmail.com   
Principal Investigator: Jee Youn Moon, M.D.         
Sponsors and Collaborators
Seoul National University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeeyoun Moon, Clinical Associate Professor, Seoul National University
ClinicalTrials.gov Identifier: NCT02737527     History of Changes
Other Study ID Numbers: 1510-130-716
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Keywords provided by Jeeyoun Moon, Seoul National University:
ultrasound
lumbar sympathetic block

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Peripheral Nervous System Diseases
Neuralgia
Polyneuropathies
Neuralgia, Postherpetic
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents