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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05930236
Acronym
BLEPAC
Enrollment
40
Registered
2023-07-05
Start date
2023-04-21
Completion date
2024-06-30
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain, Lumbar Facet Joint Syndrome

Keywords

Pain, fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, facet infiltration

Brief 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.

Detailed 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

Interventions

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.

DRUGLidocain

Linisol infiltration with depomedrol and omnipaque

DRUGMethylprednisolone

infiltration with linisol and omnipaque

infiltration with linisol and methylprednisolone

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

the medial branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) will be performed under ultrasound by caudal-cranial approach, followed by an X-ray check to verify the positioning of the needle.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correct needle placement rate0 minCheck 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)

Secondary

MeasureTime frameDescription
change in visual analog scale (VAS) pain score30 minfrom baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)
Incidence of Adverse event30 min(Hematoma, infection, intrathecal injection, spinal anesthesia)

Countries

Belgium

Contacts

Primary ContactMarie-Laure Nisolle, MD
marie-laure.nisolle@hubruxelles.be+32.2.555.56,19
Backup ContactTurgay Tuna, MD, PhD
turgay.tuna@hubruxelles.be+32.2.555.31.11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026