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Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?

A

Ain Shams University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Primary and Secondary Spontaneous Pneumothorax

Treatments

Drug: NSAID, Paracetamol
Drug: Paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT06467318
FMASU MD64/2024

Details and patient eligibility

About

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) .

Full 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 .

Enrollment

116 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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 ,.....)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

116 participants in 2 patient groups

Participants post mechanical pleurodesis taking classic pain management with NSAID
Active Comparator group
Treatment:
Drug: NSAID, Paracetamol
Participants post mechanical pleurodesis taking classic pain management without NSAID
Active Comparator group
Treatment:
Drug: Paracetamol

Trial contacts and locations

1

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Central trial contact

Hany Hassan, Professor

Data sourced from clinicaltrials.gov

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