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

June 14, 2024 updated by: Bavly Malak, Ain Shams University
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) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 1181
        • Recruiting
        • Faculty of medicine, Ain Shams university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 ,…..)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Participants post mechanical pleurodesis taking classic pain management with NSAID
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.
Active Comparator: Participants post mechanical pleurodesis taking classic pain management without NSAID
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence of pneumothorax
Time Frame: With in 6 months or earlier with any new symptoms.
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
With in 6 months or earlier with any new symptoms.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring adjusted Length of stay
Time Frame: Around 2 weeks
from day of surgery to discharge (assessed up to 2 weeks )
Around 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD64/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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