Ultrasound-guided LMBB by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method

Chronic Low-back Pain Clinical Trial

— BLEPAC  

Official title:

Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930236
• Other study ID #: P2023/034
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Erasme University Hospital
• Contact: Marie-Laure Nisolle, MD
• Phone: +32.2.555.56,19
• Email: marie-laure.nisolle[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current standard technique is radiography requiring three uni- or bilateral punctures (transverse-axial plane). The ultrasound technique is also described mainly in this plan but a new "caudal-cranial" ultrasound-guided technique was described by Chang et al in 2018 in which the major axis is used to conduct the needle to the desired area. The investigators would like to confirm that this new technique in a single puncture is also possible under ultrasound.

Description:

The convex probe is first positioned in the median longitudinal plane opposite the spinous processes of the lower lumbar vertebrae L4 and L5 with the coordinate system on the cranial side and the side opposite the mark on the sacrum side. The latter is visualized as a hyperechogenic continuous line. The probe is then moved away from the midline, the probe is slightly inclined in an oblique paramedian position looking towards the midline, and gradually slid towards laterality in order to reveal successively, the plane of the laminar interlines of the L3, L4 and L5 vertebrae, then the plane of the facelet spacing of these same vertebrae at the junction of the upper and lower articular processes, finally the plane of their transverse processes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• chronic low back pain compatible with facet lumbar syndrome with chronic pain of at least 3 months

• who have not responded to conservative treatment after at least 4 weeks

• patients without signs of dissociated pain, radiculitis, neurological diseases including stroke and Parkinson's disease, spinal instability or deformities such as scoliosis, ankylosing spondylitis, history of lumbar surgery, fracture or lumbar tumor

Exclusion Criteria:

• Pregnant or breastfeeding women

• Allergy to injected products (Depomedrol or Linisol)

• Psychiatric disorders hindering understanding of the protocol

• Local or systemic infection

• Coagulation disorder

• Obese with a BMI> 35 kg / m²

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Low Back Pain
• Lumbar Facet Joint Syndrome

Intervention

Diagnostic Test:
• Lumbar medial branch block
The lumbar medial branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) will be performed by ultrasound-guidance in a longitudinal plane and the correct placement of the needle will be verified by radiography to show if the two modalities are equivalent.

Drug:
• Lidocain
Linisol infiltration with depomedrol and omnipaque
• Methylprednisolone
infiltration with linisol and omnipaque
• Omnipaque
infiltration with linisol and methylprednisolone

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct needle placement rate	Check the correct placement of the needle placed by caudal-cranial approach by X-ray to show if the placement is correct (at the same time)	0 min
Secondary	change in visual analog scale (VAS) pain score	from baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)	30 min
Secondary	Incidence of Adverse event	(Hematoma, infection, intrathecal injection, spinal anesthesia)	30 min