Prospective Randomized Controlled Trial of Impact of Enhanced Recovery After Surgery(ERAS) for Outcomes of Total Knee and Hip Arthroplasty
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to analyze the effect of the ERAS(early recovery after surgery) protocol on total knee and hip arthroplasty compared to conventional standard protocol. Patients will be divided into two groups: ERAS protocol group and standard protocol group. On the day before the surgery, the patient group was randomly assigned by the researcher (research nurse) who did not participate in the surgical procedure. By comparing the clinical outcomes and quality of postoperative recovery of both groups, we could confirm the effect of ERAS protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMay 13, 2019
May 1, 2019
1.3 years
March 6, 2019
May 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Quality of recovery score(QoR40)
Before surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
1 day before surgery
Quality of recovery score(QoR40)
After surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
postoperative 1 day
Secondary Outcomes (20)
Length of hospital stay
From pre-surgery to discharge, up to 4 weeks
First eating time
From pre-surgery to discharge, up to 4 weeks
First assisted walking time
From pre-surgery to discharge, up to 4 weeks
Start of rehabilitation(CPM)
From pre-surgery to discharge, up to 4 weeks
Mortality
up to 6 months after surgery
- +15 more secondary outcomes
Study Arms (2)
Enhanced recovery after surgery (ERAS) patients
EXPERIMENTALPatients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the ERAS perioperative care.
Control patients
NO INTERVENTIONPatients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the traditional perioperative care.
Interventions
The patients in the ERAS group were given a pre-treatment drug \[300 mg (gabapentin, Neurontin 300mg) and 10 mg oxycontin (oxycontin, Oxycontin CR 10mg) and 2 mg prednisolone (prednisolone 10 mg, Solondo 5mg)\] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started.
Eligibility Criteria
You may qualify if:
- \. elective total knee arthroplasty for degenerative osteoarthritis
- \. elective total hip arthroplasty for osteoarthritis of osteonecrosis of femoral head
You may not qualify if:
- \. ASA class \>3
- \. severe medical comorbidities
- \. inflammatory arthritis including rheumatoid arthritis
- \. severe instability of knee or hip
- \. revision surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopedic Surgery, Yonsei University, College of Medicine
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 11, 2019
Study Start
May 10, 2019
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
May 13, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share