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

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ClinicalTrials.gov Identifier: NCT05930236
Recruitment Status : Recruiting
First Posted : July 5, 2023
Last Update Posted : July 5, 2023
Sponsor:
Information provided by (Responsible Party):
Marie-Laure Nisolle, Erasme University Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : April 21, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: LMBB

Drug: Lidocain
Linisol infiltration with depomedrol and omnipaque
Other Name: linisol

Drug: Methylprednisolone
infiltration with linisol and omnipaque
Other Name: solumedrol

Drug: Omnipaque
infiltration with linisol and methylprednisolone


Outcome Measures
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Primary Outcome Measures :
  1. Correct needle placement rate [ Time Frame: 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 :
  1. change in visual analog scale (VAS) pain score [ Time Frame: 30 min ]
    from baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)

  2. Incidence of Adverse event [ Time Frame: 30 min ]
    (Hematoma, infection, intrathecal injection, spinal anesthesia)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930236


Contacts
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Contact: Marie-Laure Nisolle, MD +32.2.555.56,19 marie-laure.nisolle@hubruxelles.be
Contact: Turgay Tuna, MD, PhD +32.2.555.31.11 turgay.tuna@hubruxelles.be

Locations
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Belgium
Hôpital Erasme Recruiting
Bruxelles, Belgium, 1070
Contact: Marie-Laure Nisolle    +3225555619    ml.nisolle@hotmail.com   
Sub-Investigator: Djamal Ghoundiwal, MD         
Sponsors and Collaborators
Erasme University Hospital
More Information
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Responsible Party: Marie-Laure Nisolle, Nisolle Marie-Laure, MD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT05930236    
Other Study ID Numbers: P2023/034
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie-Laure Nisolle, Erasme University Hospital:
Pain
fluoroscopy
Ultrasound
 Injection Site Infiltration
Chronic
facet infiltration
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists