The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
研究概览
简要总结
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Primary unilateral total hip arthroplasty;
- •2. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis;
- •3. Able and willing to provide signed informed consent.
排除标准
- •1. Simultaneously bilateral total hip arthroplasty or revision case;
- •2. Surgical History of the hip joint;
- •3. Hip joint cavity paracentesis in recent 3 months;
- •4. Stiffness with hip;
- •5. Blood coagulation disorders;
- •6. History of deep venous thrombosis;
- •7. Concomitant medical problems such as uncontrolled hypertension, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
- •8. Allergic to NSAIDs, opioid analgesics, zolpidem
- •9. Sleep apnea, Parkinson disease, dementia, depression
- •10. Use of sedatives or hypnotics
- •11. Unable to comply with polysomnographic measurement
结局指标
主要结局
To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
时间窗: 6 months
To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)
时间窗: 6 months
To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)
时间窗: 6 months
To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)
时间窗: 6 months
To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)
时间窗: 6 months
To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function
Insomnia severity index
时间窗: 6 months
次要结局
- C Reactive Protein (CRP)(6 months)
- Erythrocyte Sedimentation Rate (ESR)(6 months)
- Hematocrit(6 months)
- Number of Blood transfusion cases(1 month)
- Blood transfusion volume(1 month)
- To evaluate the swelling of operated limb by measure the thigh girth increment(6 months)
- To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score(6 months)
- To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council(6 months)
- To evaluate the function of operated limb by Harris hip score (HHS)(6 months)
- Length of hospital stay(3 months)
- To evaluate the range of motion (ROM) of operated hip(6 months)
- Number of dressing changes(1 month)
- Haemoglobin(6 months)
研究者
Liu Yang
Professor
Southwest Hospital, China