Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale
研究概览
简要总结
The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:
- Does the ESPB reduce short-term pain in participants with low back pain?
- Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?
Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.
Participants will:
Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.
排除标准
- •Do not speak English or Spanish as a primary language
- •Are incarcerated
- •Have a known pregnancy
- •Are allergic to amide-type local anesthetics
- •Are unable to tolerate positioning for the procedure
- •Have a critical illness precluding the ability to perform the procedure.
研究组 & 干预措施
Erector Spinae Plane Block
This group will receive the erector spinae plane block
干预措施: Erector Spinae Plane Block (Procedure)
Sham Procedure
This group will receive a sham injection.
干预措施: Sham Procedure (Procedure)
结局指标
主要结局
Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale
时间窗: Change from baseline to 120 minutes post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
次要结局
- Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale(Change from baseline to 30 minutes post-intervention)
- Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale(Change from baseline to 60 minutes post-intervention)
- Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days(Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up)
- Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale(Pain score assessed at 7 days post-intervention)
- Opioid medications taken in the 7 days following the intervention(Measured at 7 days post-intervention)
- Follow up visits related to low back pain in the 7 days following the intervention(Assessed at 7 days)
- Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0(Assessed at 7 days)
研究者
Michael Gottlieb
Professor of Emergency Medicine
Rush University Medical Center