The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery

Study Overview
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Brief Summary
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To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery

Conditions
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Arthroplasty, Recovery of Function, Sleep Quality

Intervention / Treatment
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* Other: rapid recovery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>rapid recovery | Other: rapid recovery<br> <br> |
| No Intervention: Controlled group<br>non-rapid recovery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC) | To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function | 6 months | 
| To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7) |  | 6 months | 
| To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI) |  | 6 months | 
| Insomnia severity index |  | 6 months | 
| To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12) |  | 6 months | 
| To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C Reactive Protein (CRP) |  | 6 months | 
| Erythrocyte Sedimentation Rate (ESR) |  | 6 months | 
| To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council |  | 6 months | 
| To evaluate the swelling of operated limb by measure the thigh girth increment | Calculated by operated limb thigh girth increment post-operation | 6 months | 
| To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score |  | 6 months | 
| To evaluate the function of operated limb by Harris hip score (HHS) |  | 6 months | 
| To evaluate the range of motion (ROM) of operated hip | ROM of operated hips post-operation | 6 months | 
| Length of hospital stay |  | 3 months | 
| Number of dressing changes | Number of dressing changes post-operation | 1 month | 
| Hematocrit | Pre-operation and post-operation hematocrit | 6 months | 
| Haemoglobin | Pre-operation and post-operation haemoglobin | 6 months | 
| Number of Blood transfusion cases |  | 1 month | 
| Blood transfusion volume |  | 1 month |