NCT00644319Unknown2 期
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 a Large Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion [TIME1]
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours
研究概览
简要总结
RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.
PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of a non-steroidal based regimen comprising ibuprofen in decreasing post-pleurodesis pain as compared to an opiate-based regimen comprising morphine sulfate in patients with malignant pleural effusion.
- To evaluate whether chest drain size influences the amount of post-pleurodesis pain.
OUTLINE: This is a multicenter study. Patients are stratified according to histological tissue type (mesothelioma vs non-mesothelioma) and thoracoscopic procedure. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
- Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
- Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
- Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:
- •Histologically proven pleural malignancy
- •Typical features of pleural malignancy seen on direct vision during thoracoscopy
- •Pleural effusion in the context of histologically proven cancer elsewhere
- •No primary lymphoma or small cell lung carcinoma
- •All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 1 month
- •Not pregnant or nursing
- •No history of GI bleeding or untreated peptic ulceration
- •No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol
- •No hypercapnic respiratory failure
- •No known intravenous drug abuse
- •No severe renal or liver disease
- •No known bleeding diathesis
- •Able to give informed consent
- •PRIOR CONCURRENT THERAPY:
- •More than 2 weeks since prior and no concurrent corticosteroid therapy
- •No concurrent warfarin therapy
- •No other concurrent analgesics
- •Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)
- •No concurrent enrollment on another clinical study
- •Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
排除标准
- 未提供
结局指标
主要结局
Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival)
次要结局
- Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
- Change in hemoglobin and white cell count from day 0 to day 3
- Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3
- Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3
- Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3
- Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%)
- Average conscious level measured by Glasgow Coma scale from day 0 to day 3
- Drug- and talc-related adverse reactions
- Complications from chest drain insertion
- Presence of chronic chest wall pain assessed at all follow-up visits
研究者
研究点 (2)
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