A Phase 1/2 interventional study of Paracetamol and NSAID, Paracetamol in Primary and Secondary Spontaneous Pneumothorax, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Ain Shams University · Phase 1/2, Interventional, and Other
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) .
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 .
178 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.
This study's planned enrollment of 116 is above the median of 100 across 115 interventional studies indexed under Pneumothorax.
Browse Pneumothorax studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: NSAID, Paracetamol
Drug: Paracetamol
Participants post mechanical pleurodesis on pneumothorax will be divided into two groups: Group A: patients taking classic pain management with NSAID. Group B: patients taking classic pain management without NSAID.
Participants post mechanical pleurodesis on pneumothorax will be divided into two groups: Group A: patients taking classic pain management with NSAID. Group B: patients taking classic pain management without NSAID.
Rate of recurrence 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, 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
Time frame: With in 6 months or earlier with any new symptoms.
Measuring adjusted Length of stay
from day of surgery to discharge (assessed up to 2 weeks )
Time frame: Around 2 weeks
Plan to share: Undecided
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Ain Shams University