Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Ronald S. Chamberlain, St. Barnabas Medical Center
ClinicalTrials.gov Identifier:
NCT01297829
First received: November 15, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Intravenous Ibuprofen
Other: IV Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by St. Barnabas Medical Center:

Primary Outcome Measures:
  • Postoperative Narcotic Use [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV Caldolor Drug: Intravenous Ibuprofen
800 mg IV ibuprofen 30 minutes preoperatively
Other Name: Caldolor
Placebo Comparator: Placebo Other: IV Placebo
IV normal saline

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297829

Locations
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Sponsors and Collaborators
St. Barnabas Medical Center
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Ronald S Chamberlain, MD, MPA, FACS St. Barnabas Medical Center
  More Information

No publications provided

Responsible Party: Ronald S. Chamberlain, Chairman and Chief Department of Surgery, St. Barnabas Medical Center
ClinicalTrials.gov Identifier: NCT01297829     History of Changes
Other Study ID Numbers: 2010-11-15
Study First Received: November 15, 2010
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Barnabas Medical Center:
ibuprofen
postoperative narcotics
visual analog pain scale
inguinal hernia repair
umbilical hernia repair

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ibuprofen
Narcotics
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014