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临床试验/NCT01698203
NCT01698203已完成4 期

Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2012年10月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Total intravenous morphine consumption (mg)

研究概览

简要总结

Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for thoracotomy who presented with contraindications to TEA.
  • Contraindications to TEA are :
  • Patient's refusal after informations about advantages and risks of the technique
  • Anti platelets treatment that can't be discontinued
  • Anticoagulants at a curative dosage
  • haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75%
  • Systemic or local infection of the puncture point
  • 2 and 3 grade atrio-ventricular heart block without pacing
  • Severe aortic valve stenosis
  • Kyphoscoliosis
  • certain neurological disorders

排除标准

  • Patient's refusal to participate in the study
  • Psychiatric disorder (impossibility to collect the informed consent)
  • Patient under juridical protection
  • On going an other study
  • Pregnancy, breastfeeding
  • Non balanced epilepsy
  • 3 grade auriculo-ventricular heart block without pacing
  • Severe hepatocellular insufficiency
  • Anti arrhythmic treatment : class III of the Vaughan William's classification
  • Skin infection of the puncture point
  • Allergy to aminoamides local anaesthetic
  • Surgical difficulties to insert paravertebral catheter

研究组 & 干预措施

placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Total intravenous morphine consumption (mg)

时间窗: the first 48 hours after surgery

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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