Erector Spinae Plane Block for Acute Low Back Pain: a Prospective Double-blind Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Rate of Success of the treatment
研究概览
简要总结
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Nowadays, no strategy has shown optimal effectiveness to improve outcome substantially. The ultrasound-guided erector spinae plane block (ESPB) is a well-known intermuscular compartment block. In the absence of red flag signs, ESPB can be performed for low back pain to reduce pain, decrease opiate requirements and limit emergency admissions for refractory pain. This study aims to evaluate the impact of the ESPB in patients suffering from NSLB.
详细描述
The study is a multicenter randomized clinical trial. The patients are recruited on the day of admission in the emergency department for Non-Specific low back pain.They are randomly assigned to receive either regional anesthesia with a local anesthetic (ESP BLOCK Group) or placebo (CONTROL Group). The primary objective is to evaluate whether the ESPB is an effective treatment for patients with NSLB pain, by reducing pain and allowing immediate mobility. The secondary objectives of this study are multidimensional and aim to compare patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinical and economic outcomes, over a six-month follow-up period.
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
- Triple (Participant, Care Provider, Investigator)
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
- •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;
- •Referred or chronic pain;
- •Patients with opioids (acute or chronic pain and/or misuse);
- •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;
- •Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…);
- •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;
- •Subject unable to read or/and write (inability to complete a self-administered questionnaire);
- •Unavailability for follow up during 6 months;
- •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);
- •Women of childbearing potential (WOCBP) without a negative of highly sensitive pregnancy test before inclusion or not using a highly effective method of contraception;
- •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.
研究组 & 干预措施
Experimental group (ESPB)
A single injection will be performed at the erector spinae plane site, 20 ml of ropivacaine 0.2% then 8 mg of dexamethasone (2 ml) will be administered sequentially through the same needle using two separate syringes in order to prevent the risk of precipitation between the two solutions. The injection will be performed unilaterally or bilaterally as per the randomization stratification
干预措施: Erector Spinae Plane Block with local anesthetic (Procedure)
Control group (placebo)
A single injection of 22 ml isotonic saline solution will be performed at the same anatomical site as the experimental group. To maintain the double-blind design, the saline solution will be administered sequentially through the same needle using two separate syringes (20 mL + 2 mL). The injection will also be performed unilaterally or bilaterally, according to the randomization stratification.
干预措施: Erector Spinae Plane Block with isotonic saline (Procedure)
结局指标
主要结局
Rate of Success of the treatment
时间窗: 30 minutes post-procedure
The primary endpoint is the success of the treatment before hospital discharge defined by a composite criteria combining the reduction of pain on mobilization (50% decrease in pain intensity) and the validation of the "Get up and go" test (in less than 20 seconds).
次要结局
- VAS Pain assessments(The day of procedure up to 6 months)
- Consumption of rescue analgesics(The day of procedure up to 6 months)
- Steps counts(The day of procedure up to 3 days)
- Quality of sleep(The day of procedure up to day 3)
- EIFEL score(on day 3)
- WOMAC scores(on day 14, month 3, and month 6)
- Health-related quality of life Scores(The day of procedure and at 6 month)
- Opioid misuse(on day 14, month 3, and month 6)
- Time to return to work(at month 6)
- Number of physiotherapy sessions(At month 6)
- Number of recurrences(at month 6)
- Brief Pain Inventory (BPI) pain scores(on day 14, month 3, and month 6)
- Quality of life SF12 Scores(at month 3 and month 6)