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临床试验/NCT01773005
NCT01773005已完成4 期

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

Anita Gupta1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Anita Gupta
入组人数
78
试验地点
1
主要终点
Visual Analog Score (VAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Caldolor

Sham Comparator

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)

干预措施: Caldolor (Drug)

Ofirmev

Active Comparator

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)

干预措施: Ofirmev (Drug)

Ofirmev

Active Comparator

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)

干预措施: Caldolor (Drug)

结局指标

主要结局

Visual Analog Score (VAS)

时间窗: Before surgery to Post-operative Day 5 (or Hospital Discharge)

First Post-op 100mm VAS pain score at rest and with movement

次要结局

  • Quality of Recovery (QoR40 scale)(Post-operative Day one)

研究者

发起方
Anita Gupta
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anita Gupta

Associate Professor

Hahnemann University Hospital

研究点 (1)

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