Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Rate of recurrence of pneumothorax
研究概览
简要总结
Investigators aim to assess if NSAIDs affect the quality of pleurodesis resulting from mechanical pleurodesis (open surgery or VATS) regarding : Primary outcome: Recurrence of pneumothorax in 6 monthes. (assessed by X ray after 2 weeks and 6 months or symptoms requiring X ray at any timing) Secondary outcome: ▪ Adjusted Length of stay ( from day zero surgery day to discharge ). ▪ Time of removal of the chest Tube .(relatively longer with air leak presence). ▪ Need of opioids (N-SAID may decrease the need of opioids) .
详细描述
Pneumothorax is a relatively common clinical problem which can occur in individuals of any age. Irrespective of aetiology (primary, or secondary to lung disorders or injury), immediate management depends on the extent of cardiorespiratory impairment, degree of symptoms and size of pneumothorax.Non-steroidal anti-inflammatory drugs (NSAIDs) are being used with increasing frequency, due to their potent analgesic effects without having side-effects on the central neural system and additionally due to the large number and varieties of these agents. The analgesic, antiinflammatory properties, and efficacy of NSAIDs in a wide variety of diseases have been already established . Wound healing and formation of adhesions involve inflammation, cell proliferation, matrix deposition, and neovascularization. The exact mechanism by which NSAIDs affect collagen deposition and the time course of the events leading to the formation of fibrin and of adhesions after pleurodesis have not been completely elucidated until now. NSAIDs can inhibit the inflammatory process and the formation of fibrosis, due to their ability to suppress prostaglandin synthesis .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presented with primary or secondary spontaneous pneumothorax
- •Age: All age groups are included
- •Approach: Open and Video assisted thoracoscopic surgery ( Open and VATS pleurodesis).
排除标准
- •Refusal of procedure or participation in the study.
- •Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis , allergy to NSAID ,.....)
研究组 & 干预措施
Participants post mechanical pleurodesis taking classic pain management with NSAID
干预措施: NSAID, Paracetamol (Drug)
Participants post mechanical pleurodesis taking classic pain management without NSAID
干预措施: Paracetamol (Drug)
结局指标
主要结局
Rate of recurrence of pneumothorax
时间窗: With in 6 months or earlier with any new symptoms.
Non-steroidal anti-inflammatory drugs (NSAIDs) are being used with increasing frequency, due to their potent analgesic effects without having side-effects on the central neural system and additionally due to the large number and varieties of these agents. The analgesic, anti inflammatory properties, and efficacy of NSAIDs in a wide variety of diseases have been already established. Wound healing and formation of adhesions involve inflammation, cell proliferation, matrix deposition, and neovascularization. The exact mechanism by which NSAIDs affect collagen deposition and the time course of the events leading to the formation of fibrin and of adhesions after pleurodesis have not been completely elucidated until now. NSAIDs can inhibit the inflammatory process and the formation of fibrosis, due to their ability to suppress prostaglandin synthesis
次要结局
- Measuring adjusted Length of stay(Around 2 weeks)
研究者
Bavly Malak
Assistant lecturer in cardio thoracic department
Ain Shams University