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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773005
• Other study ID #: CP-001-12
• Secondary ID: 20121232
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2013
• Last updated: February 26, 2016
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Hahnemann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	University Pain Institute Hahnemann Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Anita Gupta	Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Incidence of opioid-related side effects	Post-operative Day one to five (or hospital discharge)
Primary	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	Quality of Recovery (QoR40 scale)	Patient satisfaction score	Post-operative Day one