Continuous Wound Infusion in Lumbar or Thoracic Surgery
Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Rhone Alpes
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Grenoble、Rhone Alpes、法国、38000
- University Hospital, Departement of Anesthesia and Intensive Care
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- adults
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
- beneficiary of social security
Exclusion Criteria:
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
- inability to comply to protocol requirements
- psychiatric disorders or cognitive disabilities
- chronic pain or long term opioids consumption
- diabetes
- obesity (BMI > 30)
- pregnancy or lactation
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:ropivacaine 0.2%, wound infusion
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wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
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安慰剂比较:saline solution 0.9%, wound infusion
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wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
morphine consumption
大体时间:48 hours after surgery
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48 hours after surgery
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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number of patients in need of morphine in post surgery monitoring room
大体时间:1 hour after surgery
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1 hour after surgery
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morphine consumption in post surgery monitoring room
大体时间:1 hour post surgery
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1 hour post surgery
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consumption of morphine
大体时间:72 hours after surgery
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72 hours after surgery
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global self appreciation of pain management
大体时间:at 72 hours
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at 72 hours
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Time required for post surgery functional recovery
大体时间:participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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Adverse effects of morphine
大体时间:72 hours after surgery
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72 hours after surgery
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hospitalization delay
大体时间:participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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asked bolus divided by delivered bolus
大体时间:until 72 hours after surgery
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until 72 hours after surgery
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Score for pain intensity
大体时间:until 72 hours after surgery
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until 72 hours after surgery
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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