Incidence of Chronic Pain in Patients Undergoing Knee Arthroplasty Within a Fast-Track Protocol: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Chronic postoperative pain (CPSP) at three months after knee arthroplasty
研究概览
简要总结
The goal of this study is to learn about pain after knee replacement surgery. The surgery uses a fast-recovery program called Enhanced Recovery After Surgery (ERAS).
The main questions are:
How many participants still have pain three months after surgery? How severe is the pain? How many participants still use strong pain medication (opioids)? Participants are adults undergoing knee replacement surgery at UZ Gent and following the ERAS program.
Researchers will collect information on pain and recovery before surgery and for up to three months afterward. Participants will answer simple questions about their pain and daily activities.
This study will help researchers understand post-surgical recovery and may help improve pain care in the future.
详细描述
This prospective observational cohort study evaluates perioperative pain management and recovery outcomes in adult patients undergoing primary knee replacement surgery within an Enhanced Recovery After Surgery (ERAS), or fast-track, pathway at UZ Gent.
Knee arthroplasty is an established surgical intervention for patients with advanced joint disease, with the aim of improving mobility and reducing pain. The ERAS pathway integrates standardized perioperative care elements, including optimized anesthesia, multimodal analgesia, early mobilization, and reduced length of hospital stay. While ERAS protocols have demonstrated benefits regarding recovery and hospital discharge, the effect of these pathways on persistent postoperative pain and opioid use requires further evaluation.
Persistent pain after knee replacement surgery remains an important clinical outcome. A proportion of patients experience ongoing pain or functional limitations despite technically successful surgery.
Patients included in this study will undergo knee replacement surgery according to the institutional ERAS protocol. The protocol includes preoperative assessment, standardized perioperative care, and early postoperative mobilization. Suitability for the ERAS pathway is evaluated during the preoperative anesthesia consultation. Any deviations from the standardized pathway, including changes in perioperative management or rehabilitation, will be documented together with the reason for the deviation.
Patients undergoing knee replacement surgery according to the ERAS pathway will be followed prospectively from the preoperative assessment until three months after surgery. Data collected will include perioperative characteristics, pain scores, functional outcomes, neuropathic pain features, opioid use, and relevant clinical variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients suitable for a standardized approach to the primary elective knee arthroplasty surgery and recovery period.
排除标准
- •Significant comorbidities that may cause complications during the operation or the recovery period (e.g., heart and lung diseases, severe kidney disease, severe overweight).
- •Severe neurological, physical, mental, and/or cognitive conditions that may complicate rehabilitation (e.g., inability to understand or follow postoperative instructions).
- •Active infections or septic arthritis.
- •Specific surgical obstacles such as revision surgery, extensive previous joint surgery, severe limitations in movement, severe instability, or marked abnormalities.
结局指标
主要结局
Chronic postoperative pain (CPSP) at three months after knee arthroplasty
时间窗: Three months after knee arthroplasty
Pain intensity will be assessed using the Numeric Rating Scale (NRS) during movement. CPSP will be defined as an NRS score ≥4 at three months postoperatively. Severe chronic postoperative pain will be defined as an NRS score ≥6. Unit of Measure: Points on an 0-10 Numeric Rating Scale.
Functional recovery at 3 months after knee replacement
时间窗: 3 months postoperatively
Functional recovery will be assessed using the Oxford Knee Score (OKS). A score ≤14 indicates a poor functional outcome related to knee pain. Unit of Measure: Points on the Oxford Knee Score (0-48)
Neuropathic pain characteristics at 3 months
时间窗: 3 months postoperatively
Neuropathic pain features will be evaluated using the DN4 questionnaire. A DN4 score ≥4 is considered suggestive of neuropathic pain. Unit of Measure: Points on the DN4 questionnaire (0-10).
Postoperative opioid use at 3 months
时间窗: 3 months postoperatively
Postoperative opioid use will be assessed by recording whether participants use opioid medication and, if applicable, the amount of opioid medication used. Unit: Number of participants using opioids (yes/no) and/or morphine milligram equivalents (MME).
次要结局
- Postoperative pain intensity during hospital stay after knee arthroplasty(Postoperative day 1 and day 2 after knee arthroplasty)
- Preoperative and discharge pain intensity after knee arthroplasty(Preoperatively and at postoperative day 1-2-3-4 (at hospital discharge))
- Opioid consumption during the perioperative period(Perioperative period through postoperative day 1-2-3 (at hospital discharge))
- Surgical complications after knee arthroplasty(From surgery until three months postoperatively)
- Length of hospital stay after knee arthroplasty(Postoperative day 1-2-3-4)