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临床试验/NCT05282251
NCT05282251招募中不适用

Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月17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
招募中
入组人数
60
试验地点
1
主要终点
Time to first rescue analgesia

研究概览

简要总结

Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients that reach American socity of anesthesiologist class 1-3
  • Scheduled for VATS surgery under general anesthesia.

排除标准

  • ● Allergy to local anesthetics
  • Patient with pleural inflammation due to recent pneumonia
  • Patients who are unable or unwilling to perform spirometer test
  • Renal dysfunction: (Elevated creatinine > 2 mg\dl)
  • Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
  • History of addiction

研究组 & 干预措施

Intrapleural bupivacine nebulization

Experimental

Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo

干预措施: Intrapleural bupivacine nebulization (Drug)

Intravenous paracetamol and ketorolac

Active Comparator

Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo

干预措施: Intravenous paracetamol and ketorolac (Drug)

结局指标

主要结局

Time to first rescue analgesia

时间窗: The first 24 hours postoperatively

次要结局

  • Total opioid consumption(The first 24 hours postoperatively)

研究者

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

Essam El-den Moubark Mohammed Hussein

Resident doctor

Assiut University

研究点 (1)

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