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

Sleep Quality Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02852460
• Other study ID #: Rapid recovery
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2016
• Last updated: July 28, 2016
• Start date: April 2016

Study information

• Verified date: July 2016
• Source: Southwest Hospital, China
• Contact: WEINAN ZENG
• Phone: +8615023100103
• Email: weinanzeng[@]163.com
• Is FDA regulated: No
• Health authority: Third Military Medical University: China
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthroplasty
• Recovery of Function
• Sleep Quality

Intervention

Other:
• rapid recovery

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)		6 months	Yes
Primary	To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)		6 months	Yes
Primary	Insomnia severity index		6 months	Yes
Primary	To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)		6 months	Yes
Primary	To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score		6 months	Yes
Secondary	C Reactive Protein (CRP)		6 months	Yes
Secondary	Erythrocyte Sedimentation Rate (ESR)		6 months	Yes
Secondary	To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council		6 months	Yes
Secondary	To evaluate the swelling of operated limb by measure the thigh girth increment	Calculated by operated limb thigh girth increment post-operation	6 months	Yes
Secondary	To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score		6 months	Yes
Secondary	To evaluate the function of operated limb by Harris hip score (HHS)		6 months	Yes
Secondary	To evaluate the range of motion (ROM) of operated hip	ROM of operated hips post-operation	6 months	Yes
Secondary	Length of hospital stay		3 months	Yes
Secondary	Number of dressing changes	Number of dressing changes post-operation	1 month	Yes
Secondary	Hematocrit	Pre-operation and post-operation hematocrit	6 months	Yes
Secondary	Haemoglobin	Pre-operation and post-operation haemoglobin	6 months	Yes
Secondary	Number of Blood transfusion cases		1 month	Yes
Secondary	Blood transfusion volume		1 month	Yes