ROPIVACAINE HYDROCHLORIDE MONOHYDRATE for Acute low back pain | Lumbar pain

Inclusion criteria

• {"criterion_text":"- Male or female"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment."}
• {"criterion_text":"- Patient with NS pain > 6"}
• {"criterion_text":"- Patient with Oswestry score ≥ 30"}
• {"criterion_text":"- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure"}
• {"criterion_text":"- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol"}
• {"criterion_text":"- Patient affiliated to a social security or any health insurance"}

Exclusion criteria

• {"criterion_text":"- Presence of \"red flag\" (non-disc lumbago): o Motor deficit or signs of horsetail irritation o Inflammatory pain waking up in the 2nd half of the night o Tumoral context o Infectious context or fever o Altered general condition o Traumatic context o Osteoporotic context"}
• {"criterion_text":"- Pregnant or breastfeeding woman or woman refusing effective contraception"}
• {"criterion_text":"- Patient deprived of liberty or under legal protection (guardianship or curatorship)"}
• {"criterion_text":"- Patient participating in another clinical research protocol involving a drug or medical device"}
• {"criterion_text":"- Patient unable to follow the protocol, as judged by the investigator"}
• {"criterion_text":"- Patient refusing to participate in the study"}
• {"criterion_text":"- Risk of infection"}
• {"criterion_text":"- Patient with poor local skin condition"}
• {"criterion_text":"- Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)"}
• {"criterion_text":"- Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide"}
• {"criterion_text":"- Patient with sciatica"}
• {"criterion_text":"- Patient with chronic respiratory insufficiency"}
• {"criterion_text":"- Patient with cardiac rhythm disorders"}
• {"criterion_text":"- Pregnant or breastfeeding woman or woman refusing effective contraception"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Area under the curve of numeric scale (NS) pain in activity over first 4 days; values reported by participant on a monitoring log/observation book at timepoints H0, H1, H4, H8, H12 and days D1, D2, D3, D4."}

Secondary endpoints

• {"endpoint_text":"- NS (numeric scale) pain at rest at D4","definition_or_measurement_approach":"Numeric scale pain at rest measured at Day 4."}
• {"endpoint_text":"- NS pain in activity at D4","definition_or_measurement_approach":"Numeric scale pain in activity measured at Day 4."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Area under the curve of numeric scale pain at rest using values recorded at H0, H4, H8, H12 and days D1, D2, D3, D4, D7, D14, D21, D28 in the monitoring logbook/observation book."}
• {"endpoint_text":"- NS pain at D4","definition_or_measurement_approach":"Numeric scale pain measured at Day 4 (general)."}
• {"endpoint_text":"- OSWESTRY algofunctional index","definition_or_measurement_approach":"Oswestry Disability Index assessed at specified visits (J0, J4, J28)."}
• {"endpoint_text":"- Number of days off work up to D28","definition_or_measurement_approach":"Count of days of work interruption recorded up to Day 28."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Recording and categorisation of specified adverse events/complications related to procedure or drug; events grouped into categories (a)–(e) as listed."}
• {"endpoint_text":"- Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc.","definition_or_measurement_approach":"Collection of concomitant/ancillary treatments including analgesics, NSAIDs, physiotherapy, manipulations, surgical interventions."}
• {"endpoint_text":"- Schober test performed at D0 and D4","definition_or_measurement_approach":"Schober test (lumbar flexion mobility measure) performed at baseline (D0) and Day 4."}

France

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

28-05-2025

Processing Time Days

355

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Sante Atlantique

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France