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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02737527
• Other study ID #: 1510-130-716
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2016
• Last updated: June 8, 2016
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: June 2016
• Source: Seoul National University
• Contact: Jee Youn Moon, MD, PhD
• Phone: 82-10-5299-2036
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Neuralgia, Postherpetic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Polyneuropathies
• Postherpetic Neuralgia
• Reflex Sympathetic Dystrophy

Intervention

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.

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through the LSB procedure completion (day 0)	No
Secondary	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.	through the LSB procedure completion (day 0)	No
Secondary	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.	through the LSB procedure completion (day 0)	No
Secondary	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	through the LSB procedure completion (day 0)	No
Secondary	The number of the needle contact to bone during the procedure		through the LSB procedure completion (day 0)	No
Secondary	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).	through the LSB procedure completion (day 0)	No
Secondary	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	through the LSB procedure completion (day 0)	No
Secondary	Any adverse events	genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness, or other events	Up to 72 hours after the procedure	Yes
Secondary	Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain		performs telephone follow-up in 72 hours.	No
Secondary	Procedure-related NRS pain score		performs telephone follow-up in 72 hours.	No
Secondary	Changes of dose in analgesics	NSAIDs, paracetamol, and opioids	performs telephone follow-up in 72 hours.	No
Secondary	Any adverse events remained		performs telephone follow-up in 72 hours.	Yes
Secondary	A 5-pointed Likert satisfaction scale related to the procedure		performs telephone follow-up in 72 hours.	No