Status:
NOT_YET_RECRUITING
Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
Lead Sponsor:
Elsan
Conditions:
Lumbago
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ro...
Eligibility Criteria
Inclusion
- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- Patient with NS pain \> 6
- Patient with Oswestry score \> or equal to 30
- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
- Patient affiliated to a social security or any health insurance.
Exclusion
- 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
- Risk of infection
- Patient with poor local skin condition
- Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
- Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
- Patient with sciatica
- Patient with chronic respiratory insufficiency
- Patient with cardiac rhythm disorders
- Pregnant or breastfeeding woman or woman refusing effective contraception
- Patient deprived of liberty or under legal protection (guardianship or curator)
- Patient participating in another clinical research protocol involving a drug or medical device
- Patient unable to follow the protocol, as judged by the investigator
- Patient refusing to participate in the study
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06511765
Start Date
September 1 2024
End Date
October 31 2026
Last Update
July 22 2024
Active Locations (1)
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1
Santé Atlantique ELSAN
Saint-Herblain, France, 44800