Clinical trial NCT06467318: Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
Official title: Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Primary and Secondary Spontaneous Pneumothorax
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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) .

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Refusal of procedure or participation in the study.
* Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis , allergy to NSAID ,.....)

Primary outcomes:
measure: Rate of recurrence of pneumothorax
timeFrame: With in 6 months or earlier with any new symptoms.
Secondary outcomes:
measure: Measuring adjusted Length of stay
timeFrame: Around 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Ain shams university
Study officials:
References: