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

Primary Purpose

Chronic Low-back Pain, Lumbar Facet Joint Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lumbar medial branch block
Lidocain
Methylprednisolone
Omnipaque
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Pain, fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, facet infiltration

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Hôpital ErasmeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasound guided infiltration verified by fluoroscopy

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2023
Last Updated
July 3, 2023
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05930236
Brief Title
Ultrasound-guided LMBB by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method
Acronym
BLEPAC
Official Title
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Lumbar Facet Joint Syndrome
Keywords
Pain, fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, facet infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided infiltration verified by fluoroscopy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lumbar medial branch block
Other Intervention Name(s)
LMBB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocain
Other Intervention Name(s)
linisol
Intervention Description
Linisol infiltration with depomedrol and omnipaque
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
solumedrol
Intervention Description
infiltration with linisol and omnipaque
Intervention Type
Drug
Intervention Name(s)
Omnipaque
Intervention Description
infiltration with linisol and methylprednisolone
Primary Outcome Measure Information:
Title
Correct needle placement rate
Description
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)
Time Frame
0 min
Secondary Outcome Measure Information:
Title
change in visual analog scale (VAS) pain score
Description
from baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)
Time Frame
30 min
Title
Incidence of Adverse event
Description
(Hematoma, infection, intrathecal injection, spinal anesthesia)
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure Nisolle, MD
Phone
+32.2.555.56,19
Email
marie-laure.nisolle@hubruxelles.be
First Name & Middle Initial & Last Name or Official Title & Degree
Turgay Tuna, MD, PhD
Phone
+32.2.555.31.11
Email
turgay.tuna@hubruxelles.be
Facility Information:
Facility Name
Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Nisolle
Phone
+3225555619
Email
ml.nisolle@hotmail.com
First Name & Middle Initial & Last Name & Degree
Djamal Ghoundiwal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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