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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Lumbar pain in activity [Срок оценки: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Santé Atlantique ELSAN — Saint-Herblain

Идентификаторы

NCT: NCT06511765 · BLOCLOMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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