Clinical trial NCT01773005: Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Anesthetics, Intravenous
Lead sponsor: Hahnemann University Hospital
Sponsor class: OTHER
Collaborators: name: Cumberland Pharmaceuticals
First posted: 2013-01-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Visual Analog Score (VAS)
timeFrame: Before surgery to Post-operative Day 5 (or Hospital Discharge)
Secondary outcomes:
measure: Quality of Recovery (QoR40 scale)
timeFrame: Post-operative Day one
Other outcomes:
measure: Side effects
timeFrame: Post-operative Day one to five (or hospital discharge)
Locations:
city: Philadelphia
country: United States
facility: University Pain Institute Hahnemann Hospital
state: Pennsylvania
Study officials:
affiliation: Associate Director Research Management
name: Kirtanaa Voralu, MS
role: STUDY_DIRECTOR
References: