Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries

A Single Center, Randomized, Open-Label Trial to Compare the Safety and Efficacy of Caldolor Used Singly and in Combination With Ofirmev in Total Knee or Hip Arthroplasty Surgery Patients

The objective of this study is to compare the effectiveness and of perioperative use of Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Caldolor; Drug: Ofirmev

Detailed Description

Patients undergoing total knee or hip arthroplasty procedures at University Pain Institute at Hahnemann will be included in this study.

Following Institutional Review Board's approval, eligible patients will be selected from the Pre Admission Testing for total knee or hip arthroplasty surgeries planned at Hahnemann University Hospital.

The cases will be randomized in a 1:1 ratio into either Group 1 or Group 2. Group 1 will receive 800 mg Caldolor at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total up to 120 hours (5 days) Group 2 will receive 800 mg Caldolor at the induction of anesthesia and 1000 mg Ofirmev at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge or for a total up to 120 hours (5 days)

After the surgery, at the request of the patient they could receive morphine administered by patient-controlled analgesia pump, or by hospital staff.

The analgesics and procedures involved in this study are all standard of care drugs prescribed and administered by the attending anesthesiologist for control of total knee or hip arthroplasty surgery related pain. Data collected for every patient will exist in the patient's medical chart as part of their standard medical care. No additional patient procedures or activities are mandated by this study.

The data collection and analysis will be completed in duration of 1 year

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • University Pain Institute Hahnemann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients age 18-70 scheduled for total knee or hip arthroplasty surgery
• American Society of Anesthesiology physical status I, II, III

Exclusion Criteria:

• Impaired liver function
• History of substance abuse or chronic pain
• Patients known to be hypersensitive to any of the components of Caldolor or Ofirmev
• Patients less than 18 years of age.
• Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.
• Be pregnant or nursing
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Caldolor; Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)	Drug: Caldolor; Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days); Other Names: Intravenous Ibuprofen
Active Comparator: Ofirmev; Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)	Drug: Caldolor; Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days); Other Names: Intravenous Ibuprofen; Drug: Ofirmev; Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days); Other Names: Intravenous Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score (VAS)	First Post-op 100mm VAS pain score at rest and with movement	Before surgery to Post-operative Day 5 (or Hospital Discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery (QoR40 scale)	Patient satisfaction score	Post-operative Day one

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Incidence of opioid-related side effects	Post-operative Day one to five (or hospital discharge)

Collaborators and Investigators

• Sponsor: Anita Gupta
• Collaborators: Cumberland Pharmaceuticals
• Investigators: Study Director: Kirtanaa Voralu, MS, Associate Director Research Management

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Anesthetics, Intravenous
• Additional Relevant MeSH Terms: 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; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: CP-001-12; 20121232 (Other Grant/Funding Number: Cumberland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No