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

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

Study Overview

• Status: Unknown
• Conditions: Arthroplasty; Sleep Quality; Recovery of Function
• Intervention / Treatment: Other: rapid recovery

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; rapid recovery	Other: rapid recovery
NO_INTERVENTION: Controlled group; non-rapid recovery

What is the study measuring?

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
Length of hospital stay		3 months
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
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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: July 24, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): August 2, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Rapid recovery