NCT06511765 Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
| NCT ID | NCT06511765 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Elsan |
| Condition | Lumbago |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2026-09-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2026-03-24 with a primary completion date of 2026-09-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06511765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbago. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06511765 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06511765 currently recruiting?
Yes, NCT06511765 is actively recruiting participants. Contact the research team at cyhmla@gmail.com for enrollment information.
Where is the NCT06511765 trial being conducted?
This trial is being conducted at Saint-Herblain, France.
Who is sponsoring the NCT06511765 clinical trial?
NCT06511765 is sponsored by Elsan. The trial plans to enroll 40 participants.