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

Sponsor

Erasme University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05930236

Collaborator

(none)

Enrollment

Location

Arm

13.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain Lumbar Facet Joint Syndrome	Diagnostic Test: Lumbar medial branch block Drug: Lidocain Drug: Methylprednisolone Drug: Omnipaque	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 21, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ultrasound guided infiltration verified by fluoroscopy The 22G needle is introduced along a caudal-cranial axis to infiltrate at each level a volume of 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol (Methylprednisolone) 40mg with 1mL of Omnipaque (contrast product). At each level, contrast medium will be injected at the same time as the linisol-depomedrol mixture so that once the BBM under ultrasound is completed, an X-ray check is performed.	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. Other Names: LMBB Drug: Lidocain Linisol infiltration with depomedrol and omnipaque Other Names: linisol Drug: Methylprednisolone infiltration with linisol and omnipaque Other Names: solumedrol Drug: Omnipaque infiltration with linisol and methylprednisolone

Arm

Intervention/Treatment

Experimental: ultrasound guided infiltration verified by fluoroscopy

The 22G needle is introduced along a caudal-cranial axis to infiltrate at each level a volume of 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol (Methylprednisolone) 40mg with 1mL of Omnipaque (contrast product). At each level, contrast medium will be injected at the same time as the linisol-depomedrol mixture so that once the BBM under ultrasound is completed, an X-ray check is performed.

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.

Other Names:

LMBB

Drug: Lidocain

Linisol infiltration with depomedrol and omnipaque

Other Names:

linisol

Drug: Methylprednisolone

infiltration with linisol and omnipaque

Other Names:

solumedrol

Drug: Omnipaque

infiltration with linisol and methylprednisolone

Outcome Measures

Primary Outcome Measures

Correct needle placement rate [0 min]
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)

Secondary Outcome Measures

change in visual analog scale (VAS) pain score [30 min]
from baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)
Incidence of Adverse event [30 min]
(Hematoma, infection, intrathecal injection, spinal anesthesia)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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