The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
In this study the investigators will attempt to reduce the degree of inflammation (and thus
polymorphonuclear leukocyte counts) in the pleural space following a lung resection
procedure by administering the Non Steroid Anti-Inflammatory Drug (NSAID) Naproxen in tandem
with Proton Pump Inhibitor (PPI) Pantoprazole, ideally leading towards a significantly
reduced volume of transudate and exudate generated.
This will be achieved by running a placebo-controlled double blinded randomized control
trial where investigators and participants will be blinded so as to eliminate experimenter
bias. After screening for suitable participants using stringent inclusion and exclusion
criteria, patients will be administered by allied health professionals 500mg Naproxen BID
and 40mg Pantoprazole QD, or an identical placebo for four weeks following resection
surgery. Patients will undergo a thorough examination during their scheduled follow-up
appointments to monitor general vitals as well as possible gastrointestinal complications.
The primary outcome is a significant reduction (Δ100ml) of chest fluid extracted in the
intervention arm of the study in comparison to that of the control arm. Secondary outcomes
will include a reduction in length of stay measured in days between control and intervention
arms as well as a reduction in the total number of days chest tubes are retained in-situ.
Conditions such as mortality and morbidity, the onset of complications, and general
re-admission rates will also be recorded.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change in volume of pleural effusion collected
The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL
Yaron Shargall, MD, BSc, FRCSC
Canada: Health Canada