Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lumbar pain in activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment
The experimental treatment consists in one single interlaminal injection of 2x20ml Ropivacaine (0.375%) distributed over the L4-L5 (Lumbar vertebrae 4 and 5) and L5-S1 (Lumbar vertebrae 5 and sacrum 1) levels on both sides, combined with 2x4ml Dexamethasone soluble (i.e. 2x1ml). This dose and method of administration are those required for locoregional anesthesia.
干预措施: Ropivacaine and dexamethasone injection solution (Drug)
Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment
The placebo treatment consists in one single interlaminal injection of 2x20ml sodium chloride 0.9% distributed over the L4-L5 and L5-S1 levels on both sides.
干预措施: Sodium Chloride 0.9% Injection Solution (Drug)
结局指标
主要结局
Lumbar pain in activity
时间窗: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)
Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain)
次要结局
- Lumbar pain in activity(Day 4)
- Duration of the interruption of current activities(28 days)
- Consumption of concomitant lumbago treatments(From Day 0 (day of injection) to Day 4)
- Lumbar Pain < 3(Day 4)
- Algofunctional index(Day 0, Day 4 and Day 28)
- Lumbar pain at rest(At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28)
- Duration of the interruption of work(28 days)
- Complications(28 days)