Clinical trial NCT06511765: Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
Official title: Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Lumbago
Keywords: anesthetic blocks
pain
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Lumbar pain in activity
timeFrame: 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 outcomes:
measure: Consumption of concomitant lumbago treatments
timeFrame: From Day 0 (day of injection) to Day 4
measure: Lumbar pain at rest
timeFrame: Day 4
measure: Lumbar pain in activity
timeFrame: Day 4
measure: Lumbar pain at rest
timeFrame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28
measure: Lumbar Pain < 3
timeFrame: Day 4
measure: Algofunctional index
timeFrame: Day 0, Day 4 and Day 28
measure: Duration of the interruption of current activities
timeFrame: 28 days
measure: Duration of the interruption of work
timeFrame: 28 days
measure: Complications
timeFrame: 28 days
Other outcomes:
Locations:
city: St Herblain
country: France
facility: Santé Atlantique ELSAN
Study officials:
References: