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Recruiting NCT06511765

Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study

Phase III Interventional Lumbago

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine and dexamethasone injection solution, Sodium Chloride 0.9% Injection Solution.
Who it may be relevant to
Registry conditions: Lumbago. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Drug Ropivacaine and dexamethasone injection solution
    Injection of Ropivacaine and dexamethasone
  • Drug Sodium Chloride 0.9% Injection Solution
    Injection of sodium chloride 0.9%

Primary outcome measures

  • Lumbar pain in activity [Time frame: 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 (9)
  • Consumption of concomitant lumbago treatments [Time frame: From Day 0 (day of injection) to Day 4]
  • Lumbar pain at rest [Time frame: Day 4]
  • Lumbar pain in activity [Time frame: Day 4]
  • Lumbar pain at rest [Time frame: 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 [Time frame: Day 4]
  • Algofunctional index [Time frame: Day 0, Day 4 and Day 28]
  • Duration of the interruption of current activities [Time frame: 28 days]
  • Duration of the interruption of work [Time frame: 28 days]
  • Complications [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Santé Atlantique ELSAN — Saint-Herblain

Identifiers

NCT: NCT06511765 · BLOCLOMB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗