Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Intravenous Ibuprofen; Other: IV Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: IV Placebo; IV normal saline
Active Comparator: IV Caldolor	Drug: Intravenous Ibuprofen; 800 mg IV ibuprofen 30 minutes preoperatively; Other Names: Caldolor

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

Collaborators and Investigators

• Sponsor: St. Barnabas Medical Center
• Collaborators: Cumberland Pharmaceuticals
• Investigators: Principal Investigator: Ronald S Chamberlain, MD, MPA, FACS, St. Barnabas Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: ibuprofen; inguinal hernia repair; umbilical hernia repair; visual analog pain scale; postoperative narcotics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 2010-11-15