The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. The investigators are conduction this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged faster, with a greater comfort level, and a hopefully lower rate of admission.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: McMaster Surgical Associates
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Naproxen; Pantoprazole

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