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临床试验/NCT01658072
NCT01658072已完成不适用

Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Time Until Patient is Ready for Discharge

研究概览

简要总结

The best way to provide analgesia after total hip arthroplasty is hotly debated. There are two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritis, dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as part of a multimodal pain therapy. The investigators propose to compare peri-articular injection to epidural patient controlled analgesia (Epidural PCA). The investigators will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be three months following their procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
  • Age 50 to 80 years old
  • Planned use of regional anesthesia
  • Ability to follow study protocol

排除标准

  • Patients younger than 50 years old and older than 80
  • Patients intending to receive general anesthesia
  • Allergy or intolerance to one of the study medications
  • Patients with an ASA of IV
  • Patients with insulin-dependent diabetes
  • Patients with hepatic (liver) failure
  • Patients with chronic renal (kidney) failure
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Patients with any prior major ipsilateral hip surgery
  • Allergy to any of the medications (or adhesives) involved in the protocol

结局指标

主要结局

Time Until Patient is Ready for Discharge

时间窗: Length of Hospital Stay, an expected average of 3 days

"readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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