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

NCT ID: NCT02737527

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-11-30

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.

Conditions

Complex Regional Pain Syndrome; Postherpetic Neuralgia; Diabetic Polyneuropathy; Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

24G intravenous route for Lumbar Sympathetic Block (LSB):

Intervention Type: PROCEDURE

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.

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

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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.

10 ml of 0.25% levobupivacaine injection for LSB

Intervention Type: DRUG

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.

Temperature measurement for Lumbar Sympathetic Block (LSB)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

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

Group Type: ACTIVE_COMPARATOR

24G intravenous route for Lumbar Sympathetic Block (LSB):

Intervention Type: PROCEDURE

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.

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

Intervention Type: DEVICE

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.

Fluoroscope for Lumbar Sympathetic Block (LSB)

Intervention Type: DEVICE

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.

10 ml of 0.25% levobupivacaine injection for LSB

Intervention Type: DRUG

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.

Temperature measurement for Lumbar Sympathetic Block (LSB)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

lumbar sympathetic ganglion block (LSGB); lumbar sympathetic chain 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University

OTHER

Sponsor Role: lead

Responsible Party

Jeeyoun Moon

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jee Youn Moon, MD, PhD

Role: CONTACT

jymoon0901@gmail.com

82-10-5299-2036

Chang Soon Lee, MD

Role: CONTACT

iparid@gmail.com

82-2-2072-0881

Facility Contacts

Jee Youn . Moon, M.D.

Role: primary

jymoon0901@gmail.com

82-10-5299-2036

References

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.

Reference Type: DERIVED

PMID: 29189275 (View on PubMed)

Other Identifiers

1510-130-716

Identifier Type: -

Identifier Source: org_study_id