跳至主要内容
临床试验/NCT03683342
NCT03683342已完成不适用

Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Duration of analgesia

研究概览

简要总结

Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.

详细描述

Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.

After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.

The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (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

入选标准

  • Patients who are going to undergo a unilateral forefoot surgery ;
  • ASA I-III ;
  • Aged 18 years or more;
  • Weighing at least 45 kg

排除标准

  • Patient refusal and/or language/cognitive barrier
  • Pregnancy
  • Contra-indication for regional anesthesia
  • Opiate or alcohol dependency
  • Concomitant oncological disease with chemotherapy
  • Patients suffering from neuropathic pain

结局指标

主要结局

Duration of analgesia

时间窗: 24 hours after surgery

Time elapsed between block procedure and first iv request of morphine from PCA

次要结局

  • Pain score on movement at 4 postoperative hours(4 hours after surgery)
  • Pain score on movement at 12 postoperative hours(12 hours after surgery)
  • Pain score on movement at 24 postoperative hours(24 hours after surgery)
  • Pain score at rest at 12 postoperative hours(12 hours after surgery)
  • Global patient satisfaction 48h after surgery(48 hours after surgery)
  • Rate of neuropathic pain(4-6 weeks postoperatively)
  • Rate of paresthesia(Up to 24 hours after block procedure)
  • Total opioid consumption at 24h postoperatively(24 hours after surgery)
  • Pain score at rest at 4 postoperative hours(4 hours after surgery)
  • Pain score at rest at 24 postoperative hours(24 hours after surgery)
  • Block success rate(45 minutes after block procedure)
  • Complications after block(48 hours after surgery)
  • Block procedure time(Up to 10 minutes after ultrasound scanning)

研究者

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

Eric Albrecht

Program director of regional anesthesia

Centre Hospitalier Universitaire Vaudois

研究点 (2)

Loading locations...

相似试验

Comparison of Analgesic Duration of Popliteal Block... | 临床试验