Conditions: Inflammatory Response
Keywords: Ibuprofen Cytokines Recovery IV ibuprofen major surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.

Detailed description:
Human and animal studies suggest cyclooxygenase-inhibitors (COX-inhibitors) decrease the production of inflammatory mediators. Studies also suggest that COX inhibitors attenuate increases in corticosterone and eicosanoid levels after endotoxin injection. COX inhibitors also appear to have anticancer effects, inhibiting angiogenesis, tumor growth, and metastatic burden. These results suggest a role for IV ibuprofen in preventing untoward inflammatory responses, shortening post-surgical convalescence, improving patient satisfaction, and reducing the rate of complications occurring during the recovery from surgery. However, there are no studies that have evaluated the relationship between administration of IV ibuprofen, ensuing immunomodulation, and long-term outcomes.

Study Objective. The aim of the proposed study is to examine the effect of intravenous(IV) ibuprofen on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.

Arms:
arm 1: Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo. arm 2: Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo

Interventions: intervention 1: Ibuprofen intervention 2: Placebo/Saline solution
Intervention descriptions: intervention 1: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose. intervention 2: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Protocol document: