2024-511595-32-00招募中4 期
Erector Spinae Plane Block for acute low back pain: a prospective double-blind randomized multicenter study. ESP-BACK
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure
研究概览
简要总结
Evaluate the effectiveness of the erector spinae plane block (ESPB) in managing patients with non-specific low back (NSLB) pain, by reducing pain and allowing immediate mobility.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization procedure
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years)
- •Non-specific low back pain (≤ 5 days)
- •Pain score (VAS) ≥ 5 (during mobilization)
- •Inability to walk easily (failure of the "Get Up and Go" test in less than 20 seconds)
排除标准
- •Low back pain of known specific origin: spine surgery, spine trauma, discal hernia, facet joint, radicular (sciatica, cruralgia, meralgia paresthetica), muscle pain, cancer-related or rheumatological disease
- •Subject unable to read or/and write (inability to complete a self-administered questionnaire)
- •Unavailability for follow up during 6 months
- •Referred or chronic pain
- •Participation in another clinical trial involving an investigational medicinal product or medical device within 4 weeks preceding the screening date
- •Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code)
- •Patients protected by law (Art. L1121-6 and L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, minors, adults under law protection or unable to express their consent or patient under guardianship or curatorship
- •Patients not covered by a French social security scheme or not benefiting from such a scheme
- •Absence of signed informed consent form before inclusion from the patient
- •Patient already included in the study
- •Patients with opioids (acute or chronic pain and/or misuse)
- •Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…)
- •Contraindication to regional anaesthesia
- •Contraindication to ropivacaine, dexamethasone, sodium chloride, NSAID, paracetamol, tramadol
- •Known hypersensitivity to ropivacaine, dexamethasone, other amide-type local anesthetics, or any of the excipients
- •Addiction to drugs, alcohol or medication
- •Patients with anticoagulants for a curative use (not preventive)
- •Patients with cancer or risk of bone metastasis or; severe osteoporosis
- •Women of childbearing potential (WOCBP) without a negative of highly sensitive pregnancy test before inclusion or not using a highly effective method of contraception
- •Patient with severe hypotension or uncontrolled hypertension or; Heart Block (uncorrected second- or third-degree heart block without a pacemaker) or; severe bradycardia
- •Patients with severe liver or renal disease or peptic ulcer disease
- •Presence of infection or sepsis at the injection site
- •Patients with uncontrolled bacterial, viral, or protozoan infections or; systemic fungal infections or; active untreated tuberculosis or; active ocular herpes simplex infections
- •Patients with uncontrolled diabetes mellitus
- •Patients with glaucoma or history of severe glaucoma
- •Patients with severe psychiatric conditions
结局指标
主要结局
Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure
Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure
Validation of the "Get Up and Go" test (completed in less than 20 seconds) 30 minutes after the procedure
Validation of the "Get Up and Go" test (completed in less than 20 seconds) 30 minutes after the procedure
次要结局
- Patient-reported VAS pain score from day 0 to month 6
- Score of the Brief Pain Inventory (BPI) questionnaire on day 14, month 3, and month 6
- Consumption of rescue analgesic (tramadol) from day 0 to month 6 (total number of tablets)
- Steps count from day 0 to day 3
- Quality of sleep (sleep duration, sleep onset and awakeness numbers in hours) from day 0 to day 3
- Score of EIFEL questionnaire on day 3
- Score of WOMAC questionnaire on day 14, month 3, and month 6
- Number of medical consultations for low back pain up to month 6
- Number of physiotherapy sessions for low back pain up to month 6
- Number of recurrences of low back pain up to month 6
- Score of SF-12 questionnaire, at month 3 and month 6
- Side effects related to rescue analgesics (such as nausea, vomiting…) up to month 6
- Opioid misuse will be assessed with the score of POMI questionnaire on day 14, month 3, and month 6
- Number of days from the procedure to the time returning to work up to month 6
- The incremental cost-utility ratio (ICUR) at 6 months, based on costs collected in the study CRF and on utility values derived from the EQ-5D-5L questionnaire
研究者
CAPDEVILA Xavier
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (8)
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