2024-511226-32-00招募中4 期
Impact of prescribing nonsteroidal anti-inflammatory drugs in pleurodesis surgery after pneumothorax: a prospective randomized controlled double-blind multicenter noninferiority study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- Duration of pleural drainage (days).
研究概览
简要总结
show the non-inferiority, in terms of drainage time, of NSAIDs after pleurodesis surgery for the cure of pneumothorax
研究设计
- 分配方式
- Randomized
- 主要目的
- Ketoprofen Versus Placebo
- 盲法
- Double (Analyst, Carer, Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Pneumothorax for video-exclusive surgical indication With or without minor lung resection (atypical resection)
- •Age > or = 18 years old
- •Written or oral informed consent to participate in the study.
- •Affiliation to a social security scheme
- •Highly effective contraception for women of childbearing age (combined hormonal contraception (estrogen and progesterone) combined with ovulation inhibition (oral, intra-vaginal, transdermal), hormonal contraception (progesterone only) combined with ovulation inhibition (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence, etc.). )
排除标准
- •Patient under guardianship, curatorship or deprived of liberty
- •patient who refuses to participate in the study
- •Contraindication to the use of NSAIDs
- •Contraindications to the use of TRAMADOL
- •Curative anticoagulation
- •Contraindications to the use of NEFOPAM
- •Contraindications to the use of PARACETAMOL
- •Contraindications to the use of SODIUM CHLORIDE
- •Lactose intolerance
- •Hemopneumothorax
- •Purulent pleurisy
- •Polytraumatized
- •Pregnant, parturient or breastfeeding patient
结局指标
主要结局
Duration of pleural drainage (days).
Duration of pleural drainage (days).
次要结局
- Efficiency of analgesia: - Decimal Numerical Scale (END) for cough at post-operative H0 - END at rest at post-operative H0 - END at rest and cough upon leaving the recovery room - END at rest and cough at H6, D1, D2
- Recurrence of ipsilateral pneumothorax at 1 month, 6 months, 1 year
- Consumption of opioids (equivalent in mg of morphine)
- Efficiency of the gesture: - Drain productivity (mL) - Duration of bubbling (days)
- Post-operative medical and surgical complications : - Pneumonia during hospitalization (nominal) - duration of stay (days) - Need for re-intervention during stay (nominal)
研究者
ABOU ARAB Ossama
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (4)
Loading locations...
相似试验
招募中
3 期
INSTEP TrialRecurrent or persistent pneumothorax requiring VATS pleurodesisRespiratory - Other respiratory disorders / diseasesSurgery - Other surgeryACTRN12605000082606Gavin M Wright100
招募中
2 期
Non-steroidal Anti-inflammatory Drugs in PleurodesisNon-steroidal Anti-inflammatory DrugsPleurodesisPain ManagementPneumothoraxNCT06731647Centre Hospitalier Universitaire, Amiens358
招募中
1 期
Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?Primary and Secondary Spontaneous PneumothoraxNCT06467318Ain Shams University116
终止
2 期
The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung ResectionPleural Effusion MalignantPleural EffusionNCT01612975McMaster University7
招募中
3 期
Pleurodesis treatment with 50% glucoseMalignant pleural effusionIRCT20201013049017N1Esfahan University of Medical Sciences64