Comparing Ultrasound-Guided Transgluteal Nerve Block to Standard Care for Emergency Department Patients With Low Back Pain and Sciatic Radiculopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
The goal of this clinical trial is to compare transgluteal sciatic nerve block to standard of care to treat sciatic back pain in adult patients who present to the emergency department.
The main question it aims to answer is: Is a transgluteal sciatic nerve block better than standard of care in improving pain in ER patients with sciatic back pain?
If there is a comparison group: Researchers will compare patients who receive transgluteal sciatic nerve blocks to patients who receive standard of care to see if pain scores improve in ER patients with sciatic back pain.
Participants will be randomized into the transgluteal sciatic nerve block group or the control group (standard of care). Participants will be asked to answer questions about their pain and will be asked to walk a timed short distance.
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
- None
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
- •Adults aged 18 years and older
- •Presentation to ED with:
- •Acute or acute-on-chronic pain consistent with sciatica, defined as unilateral lumbosacral radicular pain radiating from the lower back or gluteal region to the posterior leg, may extend distal to the knee.
- •Pain score ≥ 5/10 on Numeric Rating Scale (NRS)
排除标准
- •Known allergy to study medications (e.g., local anesthetics)
- •Coagulopathy or current anticoagulation therapy
- •Suspected or confirmed spinal infection, or tumor
- •Neurological deficits (bowel or bladder dysfunction, leg weakness)
- •Inability to provide informed consent
研究组 & 干预措施
Transgluteal sciatic nerve block
Patients will receive an ultrasound-guided transgluteal sciatic nerve block with 10-20 mL of 0.2% ropivacaine injected around the affected sciatic nerve at the level of the greater trochanter.
干预措施: nerve block with ropivacaine (Procedure)
Standard of care
Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Pain scores
时间窗: 30 minutes after intervention, time of ED disposition (at decision point of admission to the hospital or discharge which can be up to 6 hours), 24 hours after ED visit, 48 hours after ED visit
Patients in each group will be asked their pain score 30 minutes after their received intervention and at time of ED disposition (at decision point of admission to the hospital or discharge which can be up to 6 hours). Patients will then be contacted 24 and 48 hours after intervention to ask their pain score
次要结局
- Ambulatory status(Before ED disposition, 24 and 48 hours after ED visit)
- ED Bouncback(30 days after ED visit)