The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain, measured by the 11-point numerical pain rating scale
研究概览
简要总结
The main purpose of this study is to determine if there is improvement in pain and other patient outcomes when using a continuous wound analgesia system after total knee replacement, compared to usual methods of pain control. Another purpose is to determine if the system makes it easier for nurses to care for these patients.
详细描述
Continuous local wound infusion analgesia is a relatively new way of managing post-operative pain, whereby a local anesthetic is continuously infused into the surgical area. Some studies and users have reported decreased pain, decreased opioid use, decreased post-operative nausea and vomiting, decreased length of stay, and improved patient and caregiver satisfaction with the use of continuous local wound infusion analgesia, when compared to placebo, or usual care, in arthroplasty and other surgical interventions.
Hypotheses:
Primary:
The On-Q PainBuster (continuous wound infusion analgesia) in TKA will result in improved patient pain control, compared to usual care.
Secondary:
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for TKA at the Royal Alexandra Hospital
- •Patient of Dr. Arnett
- •Deemed fit for continuous wound infusion (no allergies to Bupivacaine or related medications) by anesthesia
- •Cognitively aware, and provides informed consent
- •Elective (not trauma-related) surgery
- •Able to read, speak and understand English
- •Adult < 70 years of age
- •Intra-operative spinal anaesthesia
- •Reside within metropolitan Edmonton, in a bungalow
- •Have a caregiver at home
- •ASA risk classification of 1 or 2
- •Do not regularly use opioid medication pre-operatively
- •Have preoperative knee range of motion > 90 degrees
- •Body Mass Index < 40
- •No known hepatic or liver insufficiency
排除标准
- •Deemed unfit for continuous wound infusion due to allergies
- •Other exclusion criteria to be determined
结局指标
主要结局
Pain, measured by the 11-point numerical pain rating scale
时间窗: Post-operatively for three days then again at follow-up
次要结局
- Post-operative nausea and vomiting(Post-operatively for three days)
- Narcotic medications taken(Post-operatively for three days)
- Time to first mobilization, first transfer and first 30-M walk(Up to three days post-operatively)
- Number of adverse events(Three days post-op (observed) then at follow-up (self-report))
- Length of Stay(Time of surgery to discharge)
- Satisfaction (patient and caregiver)(Discharge from hospital)