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临床试验/NCT05173337
NCT05173337已完成不适用

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年12月8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
发起方
入组人数
46
试验地点
1
主要终点
Pain after 12 hour of surgery

研究概览

简要总结

Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.

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
Triple (Participant, 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

  • patient scheduled for elective video-assisted thoracoscopic surgery
  • American Society of Anesthesiologists physical grade I, II, III
  • patient aged from 18 years old

排除标准

  • history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
  • renal insufficiency
  • liver insufficiency
  • myocardial infarction
  • pregnant and lactating women at the time of surgery
  • patient who did not consent to the use of patient-controlled analgesia

研究组 & 干预措施

nefopam group

Experimental

Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery.

干预措施: Nefopam (Drug)

结局指标

主要结局

Pain after 12 hour of surgery

时间窗: 12 hours after surgery.

Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

Pain after 6 hour of surgery

时间窗: 6 hours hours after surgery.

Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

Pain after 1 hour of surgery

时间窗: 1 hour after surgery.

Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

Pain after 24 hour of surgery

时间窗: 24 hours after surgery.

Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

次要结局

  • Rescue analgesics(24 hours after surgery.)
  • Patient-controlled analgesia use(24 hours after surgery)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eunah Cho, MD

Assistant Professor

Kangbuk Samsung Hospital

研究点 (1)

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