Lumbago
Conditions
Keywords
anesthetic blocks, pain
Brief 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.
Interventions
DRUGRopivacaine and dexamethasone injection solution
Injection of Ropivacaine and dexamethasone
Injection of sodium chloride 0.9%
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment. 2. Patient with NS pain \> 6 3. Patient with Oswestry score \> or equal to 30 4. Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure, 5. Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol, 6. Patient affiliated to a social security or any health insurance.
Exclusion criteria
1. Presence of "red flag" (non-disc lumbago): * Motor deficit or signs of horsetail irritation * Inflammatory pain waking up in the 2nd half of the night * Tumoral context * Infectious context or fever * Altered general condition * Traumatic context * Osteoporotic context 2. Risk of infection 3. Patient with poor local skin condition 4. Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized) 5. Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide 6. Patient with sciatica 7. Patient with chronic respiratory insufficiency 8. Patient with cardiac rhythm disorders 9. Pregnant or breastfeeding woman or woman refusing effective contraception 10. Patient deprived of liberty or under legal protection (guardianship or curator) 11. Patient participating in another clinical research protocol involving a drug or medical device 12. Patient unable to follow the protocol, as judged by the investigator 13. Patient refusing to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar pain in activity | At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of concomitant lumbago treatments | From Day 0 (day of injection) to Day 4 | Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc |
| Lumbar pain at rest | Day 4 | Lumbar pain measured by the patient on a numeric scale |
| Lumbar pain in activity | Day 4 | Lumbar pain measured by the patient on a numeric scale |
| Lumbar Pain < 3 | Day 4 | Percentage of patients with pain \< 3 (measured by the patient on a numeric scale, at rest) |
| Algofunctional index | Day 0, Day 4 and Day 28 | 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. |
| Duration of the interruption of current activities | 28 days | Number of days without current activities |
| Duration of the interruption of work | 28 days | Number of days of sick leave |
| Complications | 28 days | 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 |
Countries
France
Contacts
CONTACTYves MAUGARS, PhD
CONTACTVincent WYART
Outcome results
None listed