PeriOPerative Spine Surgery COntrol Pain (POPSSCOP) Study: Intrathecal Morphine vs Erector Spinae Plane Block for Postoperative Pain Management in Spinal Fusion. Single-center Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- NRS score T0
研究概览
简要总结
This is a prospective observational study conducted at the trauma center of Città della Salute e della Scienza of Turin. The aim of the study is to compare two local regional anesthesia techniques in multimodal analgesia for spine fusion: Intrathecal Morphine (IM) and the Erector Spinae Plane Block (ESPB). The effectiveness of these techniques is to be understood in terms of improved intraoperative and postoperative pain management.
Primary outcome:
● Assessment of postoperative pain upon awakening using the NRS score (T0). The secondary outcomes are aimed at investigating whether one technique is more effective than the other in terms of reducing postoperative opioid consumption and therefore improving pain control in the first 24 hours. Any side effects and complications related to the two techniques will also be analyzed.
Patients are enrolled by signing an informed consent form before surgery. At the time of surgery, an anesthesiologist experienced in locoregional techniques performs one of the two techniques (only those who have been specially trained can perform ESPB). A shared multimodal analgesia protocol is followed intraoperatively. In the postoperative period, standard analgesic therapy is set up and in the first 24 hours parameters, pain (NRS), any rescue medications administered and side effects and complications are recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age >=18 years
- •Patients with surgical indication for thoracolumbar spinal fusion with posterior access.
- •ASA I, II, III
排除标准
- •Patient refusal
- •Emergency surgery
- •Chronic use (>12 weeks) of opioids in the preoperative period
- •Drug addiction
- •Contraindication to drugs contained in the protocol
- •Contraindications to performing a subarachnoid puncture or fascial block
结局指标
主要结局
NRS score T0
时间窗: T0: up to 20 minutes after surgery
Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score.
次要结局
- Sides effects(First 24 hours after surgery)
- Regional anesthesia complications(Up to first 24 hours after surgery)
- Opioid consumption(Consumption of morphine at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours after surgery)
- Intraoperatory opioid consumption(during the surgery)
- Rescue therapy request(During the first 24 hours post surgery)
- NRS at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours(2 hours, 4 hours, 6 hours, 12 hours, 24 hours post surgery)