Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
NCT Number: NCT06511765
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lumbago
Interventions: DRUG: Ropivacaine and dexamethasone injection solution|DRUG: Sodium Chloride 0.9% Injection Solution
Sponsor: Elsan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-10-31
Locations: Santé Atlantique ELSAN, St Herblain, 44800, France

Summary:
This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.

The BLOCLOMB comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.

Primary Outcome Measures: Lumbar pain in activity, Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain), At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)
Secondary Outcome Measures: Consumption of concomitant lumbago treatments, Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc, From Day 0 (day of injection) to Day 4|Lumbar pain at rest, Lumbar pain measured by the patient on a numeric scale, Day 4|Lumbar pain in activity, Lumbar pain measured by the patient on a numeric scale, Day 4|Lumbar pain at rest, Area under the curve of lumbar pain at rest measured by the patient on a numeric scale, At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28|Lumbar Pain < 3, Percentage of patients with pain \< 3 (measured by the patient on a numeric scale, at rest), Day 4|Algofunctional index, Oswestry questionnaire: comprises 10 questions on pain, personal care, load-bearing, walking, sitting, standing, sleep, sex life, social life and travel. Each question offers 6 answers, with a score from 0 to 6, which the patient must choose; a score of 0 corresponds to normal function, and a score of 6 to severely impaired function.

The score obtained is multiplied by 2 to obtain a percentage of disability, with 0% for no disability, and 100% for the greatest disability., Day 0, Day 4 and Day 28|Duration of the interruption of current activities, Number of days without current activities, 28 days|Duration of the interruption of work, Number of days of sick leave, 28 days|Complications, Complications will focus on the following adverse events:

1. injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise
2. fall, iatrogenic infection
3. new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome)
4. allergy, digestive complication, renal complication
5. other to be specified, 28 days