Clinical trial NCT02852460: The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty
Recovery of Function
Sleep Quality
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC)
timeFrame: 6 months
measure: To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7)
timeFrame: 6 months
measure: To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Insomnia severity index
timeFrame: 6 months
measure: To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12)
timeFrame: 6 months
measure: To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score
timeFrame: 6 months
Secondary outcomes:
measure: C Reactive Protein (CRP)
timeFrame: 6 months
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: 6 months
measure: To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council
timeFrame: 6 months
measure: To evaluate the swelling of operated limb by measure the thigh girth increment
timeFrame: 6 months
measure: To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score
timeFrame: 6 months
measure: To evaluate the function of operated limb by Harris hip score (HHS)
timeFrame: 6 months
measure: To evaluate the range of motion (ROM) of operated hip
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 3 months
measure: Number of dressing changes
timeFrame: 1 month
measure: Hematocrit
timeFrame: 6 months
measure: Haemoglobin
timeFrame: 6 months
measure: Number of Blood transfusion cases
timeFrame: 1 month
measure: Blood transfusion volume
timeFrame: 1 month
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: