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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hahnemann University Hospital
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Anita Gupta, Hahnemann University Hospital
ClinicalTrials.gov Identifier:
NCT01773005
First received: January 9, 2013
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Ofirmev
Drug: Caldolor
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hahnemann University Hospital:

Primary Outcome Measures:
  • Visual Analog Score (VAS) [ Time Frame: Before surgery to Post-operative Day 5 (or Hospital Discharge) ] [ Designated as safety issue: No ]
    First Post-op 100mm VAS pain score at rest and with movement


Secondary Outcome Measures:
  • Quality of Recovery (QoR40 scale) [ Time Frame: Post-operative Day one ] [ Designated as safety issue: No ]
    Patient satisfaction score


Other Outcome Measures:
  • Side effects [ Time Frame: Post-operative Day one to five (or hospital discharge) ] [ Designated as safety issue: Yes ]
    Incidence of opioid-related side effects


Estimated Enrollment: 78
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: 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 Name: Intravenous Acetaminophen
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 Name: Intravenous Ibuprofen

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01773005

Contacts
Contact: Anita Gupta, DO 215-762-7000 ext 4892 anita.gupta@drexelmed.edu

Locations
United States, Pennsylvania
University Pain Institute Hahnemann Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Anita Gupta, DO    215-762-7000 ext 4892    anita.gupta@drexelmed.edu   
Sub-Investigator: Marcus Zebrower, MD         
Sub-Investigator: Sonali Rao, MD         
Sponsors and Collaborators
Anita Gupta
Cumberland Pharmaceuticals
Investigators
Study Director: Kirtanaa Voralu, MS Associate Director Research Management
  More Information

No publications provided

Responsible Party: Anita Gupta, Associate Professor, Hahnemann University Hospital
ClinicalTrials.gov Identifier: NCT01773005     History of Changes
Other Study ID Numbers: CP-001-12, 20121232
Study First Received: January 9, 2013
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hahnemann University Hospital:
Anesthetics, Intravenous

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014