Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Morphine consumption for the first postoperative 24 hours
研究概览
简要总结
Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma.
The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016.
A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use.
In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study.
The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.
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
- •Patients with percutaneous arthrodesis spine surgery for fracture
- •Insured persons
- •Age 18 years
- •Being able to receive informed information
- •Have agreed to participate in writing
排除标准
- •Minor patient
- •Patient refusal
- •Lack of social security coverage
- •Under guardianship or curatorship
- •Inability to express consent
- •History of spinal surgery
- •Unable to use morphine PCA
- •Contraindication to the use of local morphines and/or anesthetics
- •Contraindication to Loco-Regional Anesthesia
- •Long-term opioid patient (Level II and Level III analgesics)
- •Patient with preoperative neuropathic pain (score greater than or equal to 4 on the DN4 questionnaire or taking anti-epileptic or anti-depressant treatments for neuropathic pain)
研究组 & 干预措施
Erector spinae plane block with naropeine [3,75 mg/mL]
Experimental group: Erector spinae plane block with naropeine [3,75 mg/mL]
干预措施: Erector spinae plane block with naropeine [3,75 mg/mL] (Procedure)
Control group : ESPB with saline 0,9%
干预措施: ESPB with saline 0,9% (Procedure)
结局指标
主要结局
Morphine consumption for the first postoperative 24 hours
时间窗: during the first 24H after the procedure
Morphine consumption for the first postoperative 24 hours(mg)
次要结局
- Evolution of postoperative pain(Every 3 hours during the first 24 hours)
- Evolution of postoperative morphine consumption 6 hours(Post-operative morphic consumption (mg) at 6 hours)
- Evolution of postoperative morphine consumption 12 hour(Post-operative morphic consumption (mg) at 12 hours)
- Evolution of postoperative morphine consumption 1 hour(Post-operative morphic consumption (mg) at postoperative 1 hour)
- Duration of stay in postanesthesia care unit (PACU)(when two consecutives Aldrete scores at 10 occure)
- intraoperative morphine consumption(during the procedure)
- Evolution of postoperative morphine consumption 3 hours(Post-operative morphic consumption (mg) at 3 hours)
- Evolution of postoperative morphine consumption 9 hours(Post-operative morphic consumption (mg) at 9 hours)