Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- first need of opiate
研究概览
简要总结
The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
详细描述
This study evaluates the analgesic efficacy in adults of bilevel, bilateral erector spinae plane (ESP) blocks after posterior cervical spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing primary posterior cervical decompression and stabilization with instrumentation involving multi-levels in the cervical region,
- •aged >18 years and <100 years
- •ASA physical status 1, 2 or 3.
排除标准
- •refuse to participate,
- •history of opioid abuse,
- •infection of the puncture site,
- •aged <18 years and >100 years
- •ASA 4 and 5
研究组 & 干预措施
Sham group
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
干预措施: 0.9%sodium chloride (Drug)
ESPB group
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine
干预措施: 0.2% ropivacaine (Drug)
结局指标
主要结局
first need of opiate
时间窗: 48 hours
Time after surgery when the patient needs opiate for the first time
次要结局
- NLR(48 hours after surgery)
- PLR(48 hours after surgery)
- Opioid consumption(48 hours)
- Numerical Rating Scale [range 0:10](48 hours after surgery)
- Numerical Rating Scale [range 0:10](4 hours after surgery)
- Numerical Rating Scale [range 0:10](8 hours after surgery)
- Numerical Rating Scale [range 0:10](12 hours after surgery)
- Numerical Rating Scale [range 0:10](16 hours after surgery)
- Numerical Rating Scale [range 0:10](20 hours after surgery)
- Numerical Rating Scale [range 0:10](24 hours after surgery)
- Numerical Rating Scale [range 0:10](36 hours after surgery)
- NLR(12 hours after surgery)
- NLR(24 hours after surgery)
- PLR(12 hours after surgery)
- PLR(24 hours after surgery)