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

NCT ID: NCT06467318

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-12-31

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 .

Conditions

Primary and Secondary Spontaneous Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Participants post mechanical pleurodesis taking classic pain management with NSAID

Group Type: ACTIVE_COMPARATOR

NSAID, Paracetamol

Intervention Type: DRUG

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 taking classic pain management without NSAID

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

NSAID, 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.

Intervention Type: DRUG

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 ,…..)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Bavly Malak

Assistant lecturer in cardio thoracic department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Ain shams university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hany Hassan, Professor

Role: CONTACT

hanyhassan77@hotmail.com

+201227373270

Facility Contacts

Hany Hassan, Professor

Role: primary

hanyhassan77@hotmail.com

+20127373270

Other Identifiers

FMASU MD64/2024

Identifier Type: -

Identifier Source: org_study_id