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Anesthetic block of the erector muscles of the lumbar spine to relieve acute lumbar pain: pilot study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511818-21-00
Acronym
BLOCLOMB
Enrollment
40
Registered
2024-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-28

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

Conditions

Acute law back pain

Brief summary

The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.

Detailed description

NS (numeric scale) pain at rest at D4, NS pain in activity at D4, The area under the curve of the NS pain at rest is based on values recorded in a monitoring logbook and observation book at H0-4-8-12 and D1-2-3-4-7-14-21-28 days., NS pain at D4, OSWESTRY algofunctional index, Number of days off work up to D28, Complications will focus on the following adverse events: (a) injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise (b) fall, iatrogenic infection (c) new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome) (d) allergy, digestive complication, renal complication (e) other to be specified, Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc., Schober test performed at D0 and D4

Interventions

DRUGROPIVACAINE NORIDEM 7
DRUGsolution injectable
DRUGDEXAMETHASONE MEDISOL 4 mg/1 ml

Sponsors

Sante Atlantique
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.

Secondary

MeasureTime frame
NS (numeric scale) pain at rest at D4, NS pain in activity at D4, The area under the curve of the NS pain at rest is based on values recorded in a monitoring logbook and observation book at H0-4-8-12 and D1-2-3-4-7-14-21-28 days., NS pain at D4, OSWESTRY algofunctional index, Number of days off work up to D28, Complications will focus on the following adverse events: (a) injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise (b) fall, iatrogenic infection (c) new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome) (d) allergy, digestive complication, renal complication (e) other to be specified, Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc., Schober test performed at D0 and D4

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026