Percutaneous Peripheral Nerve Stimulation (PPNS), for Post-surgical Pain After Shoulder Surgery: a Prospective Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cumulative morphine consumption at 48 hours after surgery
研究概览
简要总结
Despite the implementation of Enhanced Recovery After Surgery (ERAS) protocols incorporating multimodal analgesia and regional anesthesia, postoperative pain following shoulder surgery remains inadequately controlled. Percutaneous peripheral nerve stimulation (PPNS) represents a potential alternative strategy for postoperative pain management. This prospective randomized study aims to assess the efficacy of PPNS for postoperative pain control following shoulder surgery.
详细描述
All patients will receive multimodal analgesia including preoperative regional anesthesia with an ultrasound-guided interscalene block. Patients randomized to the experimental group will receive a perineural catheter allowing postoperative peripheral nerve stimulation.The aim of this study is to evaluate whether percutaneous peripheral nerve stimulation using stimulating catheters can reduce postoperative pain intensity while preserving respiratory function in patients undergoing shoulder surgery.
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
- None
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 aged over 18 years old
- •Patients scheduled for shoulder surgery under regional and general anesthesia
排除标准
- •Outpatient surgery
- •Patients scheduled for magnetic resonance imaging (MRI)
- •Patients with an implanted pacemaker
- •Patients receiving chronic opioid therapy
- •Opioid mesusage
- •Contraindication to general anesthesia
- •Contraindication to regional anesthesia
- •Contraindication to analgesics (morphine sulfate, nonsteroidal anti-inflammatory drugs or acetaminophen)
- •Any contraindication listed in the instructions for use of the investigational medical device
- •Inability to complete a self-assessment questionnaire
- •Inability to ensure follow-up for 72 hours postoperatively
- •Lack of written informed consent
研究组 & 干预措施
Neurostimulation Group
The catheter will be placed preoperatively and used to perform the interscalene block. Postoperative peripheral nerve stimulation therapy will be initiated in case of pain. Stimulation sessions of approximately 20 minutes will be delivered, with parameters adjusted according to the patient's perception within a patient-centered neuromodulation approach. Stimulation settings may be modified by the physician (20-100 Hz, pulse width 0.1 ms, intensity 0.1-0.5 mA), with a maximum of three sessions per day. If this strategy fails to provide adequate analgesia, rescue analgesia will be administered.
干预措施: Experimental: Neurostimulation Group (Device)
Control Group
Patients in the control group will receive preoperative regional anesthesia to perform an interscalene block. In case of postoperative pain, patients will receive rescue analgesia.
干预措施: Control group (Device)
结局指标
主要结局
Cumulative morphine consumption at 48 hours after surgery
时间窗: From operating room discharge to 48 hours postoperatively
The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery
次要结局
- Time required for catheter placement(Before the surgery (day 0))
- Pain intensity during regional anaesthesia placement(Before the surgery (day 0))
- Postoperative pain intensity(From admission to the Post-Anesthesia Care Unit (PACU) to 72 hours postoperatively)
- Diaphragmatic excursion assessed by ultrasound(From operating room discharge to 24 hours postoperatively)
- Sniff nasal inspiratory pressure (SNIP)(From operating room discharge to 24 hours postoperatively)
- Maximal expiratory pressure (MEP)(From operating room discharge to 24 hours postoperatively)
- Total rescue analgesic consumption during at 72 hours after surgery(From operating room discharge to 72 hours postoperatively)
- Functional recovery(At 72 hours postoperatively)