Back to resultsComparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
Primary Purpose
Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
24G intravenous route for Lumbar Sympathetic Block (LSB):
15-cm Chiba needle for Lumbar Sympathetic Block (LSB)
Ultrasound for Lumbar Sympathetic Block (LSB)
Fluoroscope for Lumbar Sympathetic Block (LSB)
10 ml of 0.25% levobupivacaine injection for LSB
Temperature measurement for Lumbar Sympathetic Block (LSB)
Postprocedure care for LSB
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring ultrasound, lumbar sympathetic block
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound with Fluoroscope
Fluoroscope only
Arm 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
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
Outcomes
Primary Outcome Measures
Difference in Procedure time (I1)
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
Success rate
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.
Onset time of block (I2)
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.
The number of needle passes
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
The number of the needle contact to bone during the procedure
Spreading pattern of contrast dye during the procedure
Spreading pattern of contrast dye will be measured by 3 patterns (normal/muscular spread pattern/ intravascular spreading).
An 11-pointed NRS pain score related to the procedure only
measured twice -1) just after the procedure at OR, and 2) at recovery room just before discharge
Any adverse events
genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events
Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
Procedure-related NRS pain score
Changes of dose in analgesics
NSAIDs, paracetamol, and opioids
Any adverse events remained
A 5-pointed Likert satisfaction scale related to the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02737527
Brief Title
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
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome, Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
Keywords
ultrasound, lumbar sympathetic block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound with Fluoroscope
Arm Type
Experimental
Arm 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
Arm Title
Fluoroscope only
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
24G intravenous route for Lumbar Sympathetic Block (LSB):
Other Intervention Name(s)
lumbar sympathetic ganglion block (LSGB), lumbar sympathetic chain block
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
15-cm Chiba needle for Lumbar Sympathetic Block (LSB)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound for Lumbar Sympathetic Block (LSB)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fluoroscope for Lumbar Sympathetic Block (LSB)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
10 ml of 0.25% levobupivacaine injection for LSB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Temperature measurement for Lumbar Sympathetic Block (LSB)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Postprocedure care for LSB
Intervention Description
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 Measure Information:
Title
Difference in Procedure time (I1)
Description
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
Time Frame
through the LSB procedure completion (day 0)
Secondary Outcome Measure Information:
Title
Success rate
Description
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.
Time Frame
through the LSB procedure completion (day 0)
Title
Onset time of block (I2)
Description
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.
Time Frame
through the LSB procedure completion (day 0)
Title
The number of needle passes
Description
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
Time Frame
through the LSB procedure completion (day 0)
Title
The number of the needle contact to bone during the procedure
Time Frame
through the LSB procedure completion (day 0)
Title
Spreading pattern of contrast dye during the procedure
Description
Spreading pattern of contrast dye will be measured by 3 patterns (normal/muscular spread pattern/ intravascular spreading).
Time Frame
through the LSB procedure completion (day 0)
Title
An 11-pointed NRS pain score related to the procedure only
Description
measured twice -1) just after the procedure at OR, and 2) at recovery room just before discharge
Time Frame
through the LSB procedure completion (day 0)
Title
Any adverse events
Description
genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events
Time Frame
Up to 72 hours after the procedure
Title
Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain
Time Frame
performs telephone follow-up in 72 hours.
Title
Procedure-related NRS pain score
Time Frame
performs telephone follow-up in 72 hours.
Title
Changes of dose in analgesics
Description
NSAIDs, paracetamol, and opioids
Time Frame
performs telephone follow-up in 72 hours.
Title
Any adverse events remained
Time Frame
performs telephone follow-up in 72 hours.
Title
A 5-pointed Likert satisfaction scale related to the procedure
Time Frame
performs telephone follow-up in 72 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jee Youn Moon, MD, PhD
Phone
82-10-5299-2036
Email
jymoon0901@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Soon Lee, MD
Phone
82-2-2072-0881
Email
iparid@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Youn . Moon, M.D.
Phone
82-10-5299-2036
Email
jymoon0901@gmail.com
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
29189275
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.
Results Reference
derived
Learn more about this trial
Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block
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