Primary and Secondary Spontaneous PneumothoraxPhase 1/2NCT06467318
Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
A Phase 1/2 study testing Paracetamol and NSAID, Paracetamol in people with Primary and Secondary Spontaneous Pneumothorax, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary and Secondary Spontaneous Pneumothorax
- What is being tested?
- Paracetamol and NSAID, Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Refusal of procedure or participation in the study.
- Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis , allergy to NSAID ,…..)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Ain shams university
Cairo, 1181
Hany Hassan, Professor, +20127373270, hanyhassan77@hotmail.com
About this study
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) .
Read the 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 .
- Being tested
- Paracetamol, NSAID, Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
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.
NSAID, ParacetamolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants post mechanical pleurodesis taking classic pain management with NSAID | Active comparator | Not described Receives: Drug: NSAID, Paracetamol |
| Participants post mechanical pleurodesis taking classic pain management without NSAID | Active comparator | Not described Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence 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, 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
Measured: With in 6 months or earlier with any new symptoms.
Secondary outcomes (1)
Measuring adjusted Length of stay
from day of surgery to discharge (assessed up to 2 weeks )
Measured: Around 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bavly Malak, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467318
- Sponsor's protocol ID
- FMASU MD64/2024
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?
- ClinicalTrials.gov ID
- NCT06467318
- Acronym / sponsor ID
- FMASU MD64/2024
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants post mechanical pleurodesis taking classic pain management with NSAID | Active comparator | Drug: NSAID, Paracetamol |
| Participants post mechanical pleurodesis taking classic pain management without NSAID | Active comparator | Drug: Paracetamol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Refusal of procedure or participation in the study.
- Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis , allergy to NSAID ,…..)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolParticipants 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. | Drug | Participants post mechanical pleurodesis taking classic pain management without NSAID |
| NSAID, ParacetamolParticipants 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. | Drug | Participants post mechanical pleurodesis taking classic pain management with NSAID |
Primary outcome
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
1 secondary outcome
Measuring adjusted Length of stay
Time frame: Around 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Primary and Secondary Spontaneous Pneumothorax
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Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paracetamol and NSAID, Paracetamol in people with Primary and Secondary Spontaneous Pneumothorax, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany Hassan, Professor (+201227373270, hanyhassan77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence of pneumothorax (time frame: With in 6 months or earlier with any new symptoms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.