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

June 8, 2016 updated by: Jeeyoun Moon, Seoul National University

Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Jee Youn Moon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through the LSB procedure completion (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through the LSB procedure completion (day 0)
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.
through the LSB procedure completion (day 0)
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
through the LSB procedure completion (day 0)
The number of the needle contact to bone during the procedure
Time Frame: through the LSB procedure completion (day 0)
through the LSB procedure completion (day 0)
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).
through the LSB procedure completion (day 0)
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
through the LSB procedure completion (day 0)
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
Up to 72 hours after the procedure
Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
Time Frame: performs telephone follow-up in 72 hours.
performs telephone follow-up in 72 hours.
Procedure-related NRS pain score
Time Frame: performs telephone follow-up in 72 hours.
performs telephone follow-up in 72 hours.
Changes of dose in analgesics
Time Frame: performs telephone follow-up in 72 hours.
NSAIDs, paracetamol, and opioids
performs telephone follow-up in 72 hours.
Any adverse events remained
Time Frame: performs telephone follow-up in 72 hours.
performs telephone follow-up in 72 hours.
A 5-pointed Likert satisfaction scale related to the procedure
Time Frame: performs telephone follow-up in 72 hours.
performs telephone follow-up in 72 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

April 9, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1510-130-716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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