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

Pleural Effusion research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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 170┬Ámol/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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pleural Effusion

Pleural Effusion Malignant

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:NaproxenIntervention arm involves administering 500mg Naproxen BID to participants and 40mg of Pantoprazole 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.

Drug:PlaceboInert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboThis 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.

NaproxenIntervention 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.

Study Status

Active, not recruiting

Start Date: April 2014

Completed Date: December 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in volume of pleural effusion collected

Secondary Outcome: Hospital length of stay; compared between intervention and control arms

Study sponsors, principal investigator, and references

Principal Investigator: Yaron Shargall, MD, BSc, FRCSC

Lead Sponsor: McMaster University

Collaborator: McMaster Surgical Associates

More information:https://clinicaltrials.gov/show/NCT01612975

Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6.

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