Electrical Stimulation for Erector Spinae Plane Catheter Insertion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Number of patients with erector spinae muscle stimulation via stimulating catheter
研究概览
简要总结
The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •elective total or total reverse shoulder arthroplasty
排除标准
- •inability to provide consent
- •history of active opioid use
- •emergency procedures
- •shoulder arthroscopy
- •partial shoulder replacement
- •shoulder resurfacing
- •any revision shoulder surgery
- •any indwelling deep brain stimulator, pacemaker, and/or other neurostimulators
结局指标
主要结局
Number of patients with erector spinae muscle stimulation via stimulating catheter
时间窗: Immediately after catheter placement (up to 5 minutes to assess)
Successful erector spinae plane needle and catheter insertion means that the needle/catheter is deep to the myofascia of the erector spinae muscle complex and superficial to the intertransverse ligaments / transverse process. Thus, any stimulation of the catheter after its placement in the erector spinae muscle complex seen under ultrasound or perceived by the patient will be documented as catheter placement failure. No visualized or perceived stimulation of the erector spinae muscle complex will be documented as catheter placement success.
次要结局
- Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus(preoperatively, 30 minutes after local anesthetic bolus)
- Opioid consumption in the PACU(from admission to discharge from the PACU (average approximately 2 hours))
- Opioid consumption on postoperative day (POD) 2(POD2 (24 hours))
- Time to perform erector spinae plane catheter(During catheter placement (up to 20 minutes))
- Worst pain score ratings in the postanesthesia care unit (PACU)(as soon as patient can respond in PACU (up to 1 hour))
- Highest and lowest vertebral level of sensory change after local anesthetic bolus(preoperatively, 30 minutes after local anesthetic bolus)
- Average postoperative pain on postoperative day (POD) 3(POD3 (24 hours))
- Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus(preoperatively, prior to local anesthetic bolus (up to 5 minutes))
- Opioid consumption on postoperative day (POD) 1(POD1 (24 hours))
- Opioid consumption on postoperative day (POD) 3(POD3 (24 hours))
- Average postoperative pain on postoperative day (POD) 1(POD1 (24 hours))
- Average postoperative pain on postoperative day (POD) 2(POD2 (24 hours))
研究者
Jan Boublik
Clinical Assistant Professor
Stanford University