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

Last updated: June 14, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chest Trauma

Treatment

NSAID, Paracetamol

Paracetamol

Clinical Study ID

NCT06467318
FMASU MD64/2024
  • All Genders
  • Accepts Healthy Volunteers

Study 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) .

Eligibility Criteria

Inclusion

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 VATSpleurodesis).

Exclusion

Exclusion Criteria:

  • Refusal of procedure or participation in the study.

  • Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis ,allergy to NSAID ,.....)

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: NSAID, Paracetamol
Phase: 1/2
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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 .

Connect with a study center

  • Faculty of medicine, Ain shams university

    Cairo, 1181
    Egypt

    Active - Recruiting

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