Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48.
研究概览
简要总结
Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis.
The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours.
In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.
The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.
详细描述
Postoperative pain after posterior lumbar stabilization surgery is related to soft tissue and muscle dissection and to manipulations and removal at the operation site. Most patients complain of severe pain at rest during the first 24 h after surgery. This pain increases considerably with mobilization because of the reflex spasm of paraspinal muscles that is triggered by the primary wound pain. During the following 48-72 h, postoperative back pain is generally moderate at rest, whereas it remains severe on movement and produces discomfort that can interfere with patient mobilization and, possibly, with discharge time. Despite the favourable effects of analgesia in the early postoperative period, this drug association may produce a number of well-known side effects, such as nausea, vomiting, respiratory depression, sedation, renal abnormality, and upper gastrointestinal and operative site bleeding. Local anesthetic infiltration of the surgical wound is a useful method in the treatment of postoperative pain after various surgical procedures. Ropivacaine is an interesting molecule for infiltration because of its vasoconstrictive properties and decreased neuro- and cardiotoxicity compared with bupivacaine.
The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours.
After we obtained approval from the ethics committee and informed, written consent from patients, patients older than 18 years old , heavier than 50 kg, without psychological disorders, benefiting from of arthrodesis scheduled by a rachis lumbar posterior way were enrolled.
Patients were randomized to one of the two following postoperative analgesia groups after a presealed envelope was opened.
Post operative pain management is standardised with paracetamol, profenid and ACP morphine for each patient.
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 benefiting from of arthrodesis scheduled by a rachis lumbar posterior way
- •Older than 18 years old
- •Heavier than 50 kg
- •Patients in the state health scheme
- •Patients having signed consent
排除标准
- •Surgery linked to an infectious, tumoral or traumatological cause
- •Patients suffering of chronic pain define as patients consuming stage 3 analgesic since more than 3 months.- Patients receiving isoptine or flécaïne before surgery
- •Arthrodesis on more than 3 stages
- •Impossibility of cooperate with the patient
- •Contra-indication for the maintain or the installation of a catheter diffusing analgesic
- •Contra-indication of using local analgesic
研究组 & 干预措施
1
Group witness: one receiving a single bolus of analgesic
Seepage simple person the end of intervention of 200mg of ropivacaïne 0,5 % at the level of zones it
干预措施: Ropivacaine (Drug)
2
Group catheter: receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48.
时间窗: 2 days
次要结局
- The consumption of morphine mg-The rate of the nausea and the postoperative vomits defined-Delay up to the first rise-Delay will be estimated in hours enter the end of the intervention surgery and the first one night(2 days)