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临床试验/NCT01638845
NCT01638845已完成不适用

Hip Fracture and Perineural Catheter

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
166
试验地点
2
主要终点
Number of participants with cardiovascular events during the preoperative period

研究概览

简要总结

INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing frequency and its high morbidity and mortality. The leading cause of death is cardiovascular decompensation, caused by painful phenomena associated with fracture and orthopedic surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in mortality but are associated with numerous side effects that prevent routine use. Peripheral analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months. Elderly patients suffering from a hip fracture, no study has investigated the effect of local analgesia continuous femoral perineural catheter on the incidence of cardiovascular events in the perioperative period.

OBJECTIVE: The main objective of this work is to show that perineural analgesia block continuous local anesthetic reduces the incidence of cardiovascular complications in the preoperative period of a patient with a hip fracture and fact, show that this technique decreases the incidence of mortality at one year of patients with a hip fracture (secondary objective).

MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It compares two populations of patients: one has a perineural analgesia by continuous infusion via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other only systemic analgesia without development of a catheter perineural (n = 157). The duration of patient participation will be 12 months. In the first 24 hours after a hip fracture after randomization, study participants will benefit from the installation under strict asepsis, a continuous block by catheter, placed by an anesthesiologist experienced control room post-interventional. The local analgesia will be provided by continuous administration via the perineural catheter, ropivacaine for 5 days for the treated group. Except the local analgesia protocol, the protocols pre-and postoperative systemic analgesia and general anesthesia will be identical for all participants of the 2 groups, similar to techniques proposed in the context of everyday clinical practice, ensuring analgesia optimal for all patients in the study. The main features will be found three bioassays Troponin IC and 3 electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition, cardiovascular clinical monitoring and quantification of pain ( will be performed daily for 8 days after inclusion. Finally, an assessment of higher functions by ladder MMS will be conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3 months and 1 year will be realized.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients with an age greater than or equal to 60 years
  • Patients who have written, informed consent was obtained
  • Patients evaluated ASA 1, 2 and 3 according to the classification of the American Society of Anesthesiologists (detailed below)
  • Patients undergoing surgery for hip fracture
  • Time less than 24 hours after a hip fracture

排除标准

  • cons indication to regional anesthesia (constitutional or acquired disorder of coagulation, sepsis, local infection of the puncture area, history of vascular surgery prosthetic femoral neuropathy scalable, allergy to local anesthetics)
  • weight <40Kg
  • Patients receiving treatment hypocoagulable or antiplatelet therapy of type dipyridamole, ticlopidine and platelet αIIbβ3 receptor antagonists (excluding aspirin and clopidogrel)
  • cons-indication for standardized anesthetic technique in this study
  • cons-indication for analgesics used postoperatively (respiratory failure, severe liver failure, brain injury associated with intracranial hypertension, uncontrolled epilepsy, simultaneous treatment with MAOIs, hypersensitivity to opioids)
  • Patient unable to give informed consent
  • adults under guardianship or curator
  • persons not affiliated with a health insurance plan
  • A person deprived of liberty

结局指标

主要结局

Number of participants with cardiovascular events during the preoperative period

时间窗: 3 days

次要结局

未报告次要终点

研究者

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

研究点 (2)

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