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临床试验/NCT02949674
NCT02949674已完成3 期

Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
93
试验地点
1
主要终点
VAS

研究概览

简要总结

Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber classification system divides ankle fractures in three types according to the anatomy of lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and internal fixation. However, it's been reported that even with successful reduction surgically great results are not always achieved. Local wound infiltration blocks the pain in its origin, surgical site by itself, without alter motor function. Practically without presenting adverse events with this method. it´s accurate for ambulatory surgery.

Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction and internal fixation.

Method: Two groups with ankle fractures which will be informed and the patients will sign informed consent, after that the patients will be assign to a group (Ropivacaine or bupivacaine). The patient will be prepared for surgical treatment according to his doctor. It will be applied traditional anesthesia. It will be applied before beginning surgery in bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting surgery. After that the patient will have the traditional dose of analgesic treatment.The group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group will register data and will make statistic analysis. It will be elaborated the conclusion an elaboration of a report.

Resources: The group counts with human resources of the group of investigators. The hospital has in emergency department almost three patients with ankle fractures each day which require surgical treatment. The hospital has x ray service to valuate the ankle fracture and with computer system to analyze it. The hospital has the software for statistical analysis.

Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment of ankle fractures. Investigators have the support of pain medicine group in hospital and with anesthesia coordinators. Investigators have a group of orthopedic residents which will be encharged of ilfiltration wound site.

Time: September 2016 to February 2017.

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
Single (Participant)

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

  • Patient with afiliation to IMSS
  • Patient with ankle fracture that requires surgical treatment with open reduction and internal fixation
  • Patient that accept to participate in the study whit a sign of document.

排除标准

  • Politrauma patients (Patients with another fracture)
  • Patients who dont accept to participate in the study
  • Neuropathy in inferior limps that limits pain perception
  • Open ankle fractures

研究组 & 干预措施

Bupivacaine

Experimental

It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.

干预措施: Bupivacaine (Drug)

Ropivacaine

Experimental

It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

VAS

时间窗: Change in Visual Analogue Scale at 24 hours

The Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

JUAN LOPEZ VALENCIA

Principal Investigator

Instituto Mexicano del Seguro Social

研究点 (1)

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