The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
Pleural Effusion, Pleural Effusion Malignant
About this trial
This is an interventional treatment trial for Pleural Effusion focused on measuring Chest tubes, Length of stay, Pleural effusion, Lung resection, Post-operative, Lung cancer
Eligibility Criteria
Inclusion Criteria:
- Participants must be 18 years of age or older
- Participants must be undergoing a major lung resection due to primary or secondary malignancy
- Must have an aptitude for following directions and commitment to the study
Exclusion Criteria:
- Patients who are unable to read and communicate in English
- Patients undergoing a pneumonectomy or Open lung resection
- Previous treatments on the same anatomical side including chemotherapy, radiation therapy, and radio-frequency ablation
- Patients who have undergone decortication for empyema or malignancy.
- Patients who have a chest tube in-situ for persistent air leak
- Patients with clinical or laboratory indicators of renal failure, defined as serum creatinine level of 170µmol/l
- Patients with active or previous history of peptic ulcer disease
- Patients with a known intolerance to Proton Pump Inhibitors (PPIs)
- Known allergy to study drugs
- Use of NSAIDs 4 weeks prior to randomization or on-going use of NSAIDs.
- The use of any medications known to reduce inflammation, including but not limited to: steroids (both oral and intravenously), methotrexate, COX-II inhibitors, other NSAIDs
- Chest tube for persistent air leak.
- Patients who are pregnant or lactating
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Naproxen
This study arm will encompass the administration of a placebo (physically identical to Naproxen) orally to participants. Naproxen is a painkiller with intrinsic anti-inflammatory properties, while the placebo has no pharmacological properties associated with it. Participants will also be taking Pantoprazole to negate the gastrointestinal consequences of Naproxen (or the placebo). Participants will not know which arm of the study they belong to. In addition, they will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety.
Intervention arm involves administering 500mg Naproxen twice a day to participants and 40mg of Pantoprazole once a day in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to.