ROPIVACAINE HYDROCHLORIDE for Acute low back pain | Non-specific low back pain

Stratification factors

• study centers
• side of the block administration (unilateral or bilateral)

Inclusion criteria

• {"criterion_text":"- Adult (≥ 18 years)\n- Non-specific low back pain (≤ 5 days)\n- Pain score (VAS) ≥ 5 (during mobilization)\n- Inability to walk easily (failure of the \"Get Up and Go\" test in less than 20 seconds)"}

Exclusion criteria

• {"criterion_text":"- Low back pain of known specific origin: spine surgery, spine trauma, discal hernia, facet joint, radicular (sciatica, cruralgia, meralgia paresthetica), muscle pain, cancer-related or rheumatological disease\n- Subject unable to read or/and write (inability to complete a self-administered questionnaire)\n- Unavailability for follow up during 6 months\n- Referred or chronic pain\n- Participation in another clinical trial involving an investigational medicinal product or medical device within 4 weeks preceding the screening date\n- Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code)\n- Patients protected by law (Art. L1121-6 and L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, minors, adults under law protection or unable to express their consent or patient under guardianship or curatorship\n- Patients not covered by a French social security scheme or not benefiting from such a scheme\n- Absence of signed informed consent form before inclusion from the patient\n- Patient already included in the study\n- Patients with opioids (acute or chronic pain and/or misuse)\n- Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…)\n- Contraindication to regional anaesthesia\n- Contraindication to ropivacaine, dexamethasone, sodium chloride, NSAID, paracetamol, tramadol\n- Known hypersensitivity to ropivacaine, dexamethasone, other amide-type local anesthetics, or any of the excipients\n- Addiction to drugs, alcohol or medication\n- Patients with anticoagulants for a curative use (not preventive)\n- Patients with cancer or risk of bone metastasis or; severe osteoporosis\n- Women of childbearing potential (WOCBP) without a negative of highly sensitive pregnancy test before inclusion or not using a highly effective method of contraception\n- Patient with severe hypotension or uncontrolled hypertension or; Heart Block (uncorrected second- or third-degree heart block without a pacemaker) or; severe bradycardia\n- Patients with severe liver or renal disease or peptic ulcer disease\n- Presence of infection or sepsis at the injection site\n- Patients with uncontrolled bacterial, viral, or protozoan infections or; systemic fungal infections or; active untreated tuberculosis or; active ocular herpes simplex infections\n- Patients with uncontrolled diabetes mellitus\n- Patients with glaucoma or history of severe glaucoma\n- Patients with severe psychiatric conditions"}

Primary endpoints

• {"endpoint_text":"- Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure","definition_or_measurement_approach":"Reduction defined as a 50% decrease in pain intensity measured 30 minutes after the procedure (pain on mobilization)."}
• {"endpoint_text":"- Validation of the \"Get Up and Go\" test (completed in less than 20 seconds) 30 minutes after the procedure","definition_or_measurement_approach":"Validation determined by completion of the Get Up and Go test in less than 20 seconds, assessed 30 minutes after the procedure."}

Secondary endpoints

• {"endpoint_text":"- Patient-reported VAS pain score from day 0 to month 6","definition_or_measurement_approach":"Patient-reported visual analogue scale (VAS) pain scores collected from day 0 through month 6."}
• {"endpoint_text":"- Score of the Brief Pain Inventory (BPI) questionnaire on day 14, month 3, and month 6","definition_or_measurement_approach":"BPI questionnaire scores assessed at day 14, month 3 and month 6."}
• {"endpoint_text":"- Consumption of rescue analgesic (tramadol) from day 0 to month 6 (total number of tablets)","definition_or_measurement_approach":"Total number of tramadol tablets consumed from day 0 to month 6 recorded."}
• {"endpoint_text":"- Steps count from day 0 to day 3","definition_or_measurement_approach":"Number of steps recorded from day 0 to day 3."}
• {"endpoint_text":"- Quality of sleep (sleep duration, sleep onset and awakeness numbers in hours) from day 0 to day 3","definition_or_measurement_approach":"Sleep metrics (duration, sleep onset latency, number of awakenings in hours) measured from day 0 to day 3."}
• {"endpoint_text":"- Score of EIFEL questionnaire on day 3","definition_or_measurement_approach":"EIFEL questionnaire score assessed on day 3."}
• {"endpoint_text":"- Score of WOMAC questionnaire on day 14, month 3, and month 6","definition_or_measurement_approach":"WOMAC questionnaire scores assessed at day 14, month 3 and month 6."}
• {"endpoint_text":"- Number of medical consultations for low back pain up to month 6","definition_or_measurement_approach":"Count of medical consultations for low back pain recorded up to month 6."}
• {"endpoint_text":"- Number of physiotherapy sessions for low back pain up to month 6","definition_or_measurement_approach":"Count of physiotherapy sessions for low back pain recorded up to month 6."}
• {"endpoint_text":"- Number of recurrences of low back pain up to month 6","definition_or_measurement_approach":"Number of recurrence episodes of low back pain tracked up to month 6."}
• {"endpoint_text":"- Score of SF-12 questionnaire, at month 3 and month 6","definition_or_measurement_approach":"SF-12 questionnaire scores assessed at month 3 and month 6."}
• {"endpoint_text":"- Side effects related to rescue analgesics (such as nausea, vomiting…) up to month 6","definition_or_measurement_approach":"Adverse events related to rescue analgesics (e.g., nausea, vomiting) recorded up to month 6."}
• {"endpoint_text":"- Opioid misuse will be assessed with the score of POMI questionnaire on day 14, month 3, and month 6","definition_or_measurement_approach":"POMI questionnaire scores assessed at day 14, month 3 and month 6 to evaluate opioid misuse."}
• {"endpoint_text":"- Number of days from the procedure to the time returning to work up to month 6","definition_or_measurement_approach":"Number of days from procedure until return to work measured up to month 6."}
• {"endpoint_text":"- The incremental cost-utility ratio (ICUR) at 6 months, based on costs collected in the study CRF and on utility values derived from the EQ-5D-5L questionnaire","definition_or_measurement_approach":"ICUR at 6 months calculated from study CRF cost data and utility values derived from EQ-5D-5L responses."}

France

Earliest CTIS Part Ii Submission Date

13-11-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

13

Number Of Sites

8

Number Of Participants

300

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Monetary support","organisation_type":""}