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临床试验/NCT02577068
NCT02577068已完成不适用

Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
VAS score on wound site and posterior neck

研究概览

简要总结

Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient who undergone open thyroidectomy
  • 20~70 years old
  • ASA I~III

排除标准

  • hypersensitivity on Nefopam and Propacetamol
  • Liver failure, chronic alcohol addiction
  • severe hemolytic anemia, chronic nutrition deficiency
  • history of seizure
  • MI, MAO inhibitor
  • pregnant, breast-feeding
  • foreigners

研究组 & 干预措施

nefopam group

Active Comparator

干预措施: Nefopam (Drug)

propacetamol group

Active Comparator

干预措施: Propacetamol (Drug)

nefopam and propacetamol group

Experimental

干预措施: Nefopam (Drug)

nefopam and propacetamol group

Experimental

干预措施: Propacetamol (Drug)

结局指标

主要结局

VAS score on wound site and posterior neck

时间窗: one hour after the surgery

Patients' subject pain score through VAS on the surgery wound site and posterior neck.

次要结局

  • Postoperative nausea and vomiting(for postop. 24hrs.)
  • Patient satisfaction(for postop. 24hrs.)
  • Additional pain rescue drug(for postop. 24hrs.)
  • Chronic pain and neurogenic pain(three month after the surgery.)
  • acute VAS on wound site and posterior neck(postop. 24hrs.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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