2024-511818-21-00招募中3 期
Anesthetic block of the erector muscles of the lumbar spine to relieve acute lumbar pain: pilot study
Sante Atlantique2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月1日最近更新:
干预措施
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
- The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.
研究概览
简要总结
The main objective is to validate the efficacy of anesthetic blocks of the erector spinae muscles, over the first 4 days, on the pain of muscle contractures, during a recent lumbago.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age ≥ 18 years
- •Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- •Patient with NS pain > 6
- •Patient with Oswestry score ≥ 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): o Motor deficit or signs of horsetail irritation o Inflammatory pain waking up in the 2nd half of the night o Tumoral context o Infectious context or fever o Altered general condition o Traumatic context o Osteoporotic context
- •Pregnant or breastfeeding woman or woman refusing effective contraception
- •Patient deprived of liberty or under legal protection (guardianship or curatorship)
- •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
- •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
研究组 & 干预措施
ROPIVACAINE NORIDEM 7,5 mg/mL, solution injectable
Test
干预措施: ROPIVACAINE NORIDEM 7,5 mg/mL, solution injectable (Drug)
DEXAMETHASONE MEDISOL 4 mg/1 ml, solution injectable
Test
干预措施: DEXAMETHASONE MEDISOL 4 mg/1 ml, solution injectable (Drug)
Chlorure de sodium 0.9%
Placebo
干预措施: Chlorure de sodium 0.9% (Drug)
结局指标
主要结局
The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.
The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.
次要结局
- NS (numeric scale) pain at rest at D4
- NS pain in activity at D4
- The area under the curve of the NS pain at rest is based on values recorded in a monitoring logbook and observation book at H0-4-8-12 and D1-2-3-4-7-14-21-28 days.
- NS pain at D4
- OSWESTRY algofunctional index
- Number of days off work up to D28
- Complications will focus on the following adverse events: (a) injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise (b) fall, iatrogenic infection (c) new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome) (d) allergy, digestive complication, renal complication (e) other to be specified
- Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc.
- Schober test performed at D0 and D4
研究者
Yves Maugars
Scientific
Sante Atlantique
研究点 (2)
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