Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.

Key facts

Study ID

NCT01707251

Run by

Jacobi Medical Center

People needed

100

Starts

2012-10-01

Expected to finish

2015-03-01

Last updated by the study team

2015-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center

You may not qualify if…

• Patients with history of ibuprofen or aspirin allergy
• morphine allergy
• opioid or psychotropic medication use pre-operatively
• positive preoperative U-tox screening
• unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity
• GFR <60 or history of GI bleed within 6 weeks

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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