Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
研究概览
简要总结
The goal of this clinical trial is to compare the Erector Spinae plane (ESP) block, a nerve block, to usual care in emergency department patients with back pain. The main question it aims to answer:
Is the ESP block superior to usual care in the treatment of back pain in the emergency department? Participants will be randomly assigned to the ESP or the usual care group. Pain improvement at the time of emergency department discharge will be compared.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Participants in both cohorts had pink chlorhexidine skin prep and a dressing applied to the back. Research team members performing the telephone follow-up were blinded to treatment allocation.
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
- •Patients deemed to have mechanical back pain with a component of paravertebral tenderness or paravertebral spasm reported by the patient or noted on examination by treating physician.
排除标准
- •previous recipient of erector spinae plane block
- •exam concerning for cauda equina syndrome
- •current IV drug use
- •organ transplant recipient
- •history of or suspected bleeding diathesis
- •current use of anticoagulants
- •sepsis or soft tissue infection at site of the block within last three months
- •pregnancy
- •overt malignancy involving skin or underlying soft tissue at the site of block
- •allergy to any of the research medications
- •inability to participate in telephone follow-up
研究组 & 干预措施
ESP cohort
Randomized to receive the ultrasound-guided ESP block.
干预措施: Erector Spinae plane block using 20 ml of bupivicaine 0.25% (Procedure)
Usual care cohort
Randomized to usual care as dictated by the treating emergency physician
干预措施: Usual care (Drug)
结局指标
主要结局
Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
时间窗: Numeric verbal pain score (NVPS) at time of randomization compared with NVPS at time of discharge from the emergency department up to 24 hours after randomization.
The NVPS is an 11-point verbal pain scale from 0 to 10 with 0 representing no pain and 10 the worst pain imaginable.
次要结局
- Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use(Time of randomization to time of ED discharge up to 24 hours after randomization.)
- Emergency department (ED) length of stay.(Time of ED triage to time of ED discharge up to 24 hours after triage.)
- Brief Pain Inventory (BPI) score reduction from baseline(Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit)
- Number of patients requiring post Emergency department discharge opiate analgesia use(Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.)
- Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)(1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.)
- Number of patients able to ambulate post ED treatment if unable to on ED admission(Time of ED triage compared to time of ED discharge up to 24 hours after triage.)
- Number of patients requiring Emergency department (ED) return visits for back pain(Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.)
研究者
Ben Ho
Emergency department staff physician
Island Health