Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- morphine consumption
研究概览
简要总结
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •> 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
排除标准
- •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
- •obesity (BMI > 30)
- •pregnancy or lactation
研究组 & 干预措施
ropivacaine 0.2%, wound infusion
干预措施: Ropivacaine (Drug)
saline solution 0.9%, wound infusion
干预措施: Saline solution 0.9% (Drug)
结局指标
主要结局
morphine consumption
时间窗: 48 hours after surgery
次要结局
- number of patients in need of morphine in post surgery monitoring room(1 hour after surgery)
- morphine consumption in post surgery monitoring room(1 hour post surgery)
- consumption of morphine(72 hours after surgery)
- global self appreciation of pain management(at 72 hours)
- Time required for post surgery functional recovery(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Adverse effects of morphine(72 hours after surgery)
- hospitalization delay(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- asked bolus divided by delivered bolus(until 72 hours after surgery)
- Score for pain intensity(until 72 hours after surgery)