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临床试验/NCT00896285
NCT00896285已完成不适用

TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.

University of California, Davis2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)

研究概览

简要总结

Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.

The investigators hope to find the best way to prevent pain during pleurodesis.

详细描述

Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. Talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. This procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. Reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure.

This trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. It will also address whether either of these influences success rate of pleurodesis.

We hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. We hope to find the best way of preventing pain during this procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

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

  • Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
  • Histologically proven pleural malignancy OR
  • Typical features of pleural malignancy seen on direct vision during thoracoscopy OR
  • Pleural effusion in the context of histologically proven cancer elsewhere
  • Expected survival more than 1 month
  • Written informed consent

排除标准

  • Age < 18 years
  • Primary lymphoma or small cell lung carcinoma
  • Patients who are pregnant or lactating
  • Inability to give informed consent
  • History of GI bleeding or of untreated peptic ulceration
  • Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen
  • Hypercapnic respiratory failure
  • Known intravenous drug abuse
  • Severe renal or liver disease
  • Known bleeding diathesis
  • Warfarin therapy
  • Current or recent (within 2 weeks) corticosteroid steroid therapy

结局指标

主要结局

Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion)

时间窗: 3 months

An average pain score over 72 hours post pleurodesis for malignant pleural effusion

时间窗: 72 hours

次要结局

  • Presence of chronic chest pain on the side of the pleurodesis(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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