Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Study Overview
=================
Brief Summary
-----------------
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug. The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.

Official Title
-----------------
Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Intravenous Ibuprofen
* Other: IV Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary inguinal and/or umbilical hernia repair age > 18 years old Exclusion Criteria: history of gastrointestinal bleeding allergy to ibuprofen creatinine > 1.5 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV Caldolor<br> | Drug: Intravenous Ibuprofen<br>* 800 mg IV ibuprofen 30 minutes preoperatively<br>* Other names: Caldolor;|
| Placebo Comparator: Placebo<br> | Other: IV Placebo<br>* IV normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Narcotic Use | Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Visual Analog Pain Scale | The patient will receive a Visual Analog Pain Scale to complete 2 hrs post-operatively, post-operative day 1, post-operative day 3 and post-operative day 7 | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair