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

Not Applicable

• Conditions: Sleep Quality; Recovery of Function; Arthroplasty
• Interventions: Other: rapid recovery

• Registration Number: NCT02852460
• Lead Sponsor: Southwest Hospital, China

Brief Summary

To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Study First Posted: 2016-08-02
• Last Update Posted: 2016-08-02
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	rapid recovery	rapid recovery

Primary Outcome Measures

Name	Time	Method
To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score	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
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, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)	6 months	To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function
Insomnia severity index	6 months

Secondary Outcome Measures

Name	Time	Method
C Reactive Protein (CRP)	6 months
Erythrocyte Sedimentation Rate (ESR)	6 months
Hematocrit	6 months	Pre-operation and post-operation hematocrit
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	Calculated by operated limb thigh girth increment post-operation
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	ROM of operated hips post-operation
Number of dressing changes	1 month	Number of dressing changes post-operation
Haemoglobin	6 months	Pre-operation and post-operation haemoglobin

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China