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临床试验/NCT01960595
NCT01960595Unknown4 期

Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
4 期
入组人数
90
试验地点
2
主要终点
provides adequate pain relief and decreases fentanyl consumption

研究概览

简要总结

The purpose of this study is to investigate the efficacy and cost analysis of intravenous fentanyl combined with either local anesthesia infiltration or peroneal nerves block in patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with patients without local anesthetics administration perioperatively.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with American Society of Anesthesiologists physical status I-III
  • aged 20-65 years
  • Requiring local anesthesia and PCA use
  • No severe cardiac or pulmonary diseases
  • BMI <35 kg/m2

排除标准

  • BMI ≧35 kg/m2
  • age > 65years
  • allergy to opioid or local anesthetics

结局指标

主要结局

provides adequate pain relief and decreases fentanyl consumption

时间窗: including of surgery and 36 hours after surgery

Patients are subgrouping into groups of post-OP IV fentanyl PCA only, pretreatment of local bupivacaine infiltration and post-OP IV fentanyl PCA, and pretreatment of peroneal nerves block and post-OP IV fentanyl PCA. Resting pain and moving pain scores are measured by the numeric rating scale and classified into none, mild, moderate and severe pain four grades. Pains scale and side effects are recorded at time intervals of post-OP 0 hours, 6 hours, 12 hours, 24 hours, and 36 hours after surgery.

次要结局

  • incidence of side effects and complications(intraoperatively and 36 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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