Overview

Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jacobi Medical Center
Collaborators:
Cumberland Pharmaceuticals
Sagatech Electronics Inc, Alberta, Canada
Treatments:
Ibuprofen
Criteria
Inclusion Criteria:

- Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center

Exclusion Criteria:

- 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