Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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 Names:
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:
|
Outcome Measures
Primary Outcome Measures
- Visual Analog Score (VAS) [Before surgery to Post-operative Day 5 (or Hospital Discharge)]
First Post-op 100mm VAS pain score at rest and with movement
Secondary Outcome Measures
- Quality of Recovery (QoR40 scale) [Post-operative Day one]
Patient satisfaction score
Other Outcome Measures
- Side effects [Post-operative Day one to five (or hospital discharge)]
Incidence of opioid-related side effects
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Pain Institute Hahnemann Hospital | Philadelphia | Pennsylvania | United States | 19102 |
Sponsors and Collaborators
- Anita Gupta
- Cumberland Pharmaceuticals
Investigators
- Study Director: Kirtanaa Voralu, MS, Associate Director Research Management
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-001-12
- 20121232