Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intravenous Ibuprofen
IV Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair
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
Sites / Locations
- Saint Barnabas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IV Caldolor
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Postoperative Narcotic Use
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01297829
First Posted
November 15, 2010
Last Updated
December 12, 2014
Sponsor
St. Barnabas Medical Center
Collaborators
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01297829
Brief Title
Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Barnabas Medical Center
Collaborators
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Caldolor
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Intravenous Ibuprofen
Other Intervention Name(s)
Caldolor
Intervention Description
800 mg IV ibuprofen 30 minutes preoperatively
Intervention Type
Other
Intervention Name(s)
IV Placebo
Intervention Description
IV normal saline
Primary Outcome Measure Information:
Title
Postoperative Narcotic Use
Description
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Postoperative Visual Analog Pain Scale
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald S Chamberlain, MD, MPA, FACS
Organizational Affiliation
St. Barnabas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
We'll reach out to this number within 24 hrs