BLEPAC
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method
Sponsor study identifier
interventional
40
1 country
1
Study Start
April 21, 2023
Actual (reported)Primary Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 21, 2023
Actual (reported)June 22, 2023
Actual (reported)July 5, 2023
Actual (reported)June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
change in visual analog scale (VAS) pain score
30 min
Incidence of Adverse event
30 min
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.
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.
Hôpital Erasme
Brussels, 1070, Belgium
First Submitted
June 22, 2023
First Posted
July 5, 2023
Study Start
April 21, 2023
Actual (reported)Linisol infiltration with depomedrol and omnipaque
infiltration with linisol and omnipaque
infiltration with linisol and methylprednisolone
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Primary Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 5, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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