Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty
- Conditions
- Arthroplasty, Replacement, Hip, Knee
- Interventions
- Procedure: The non-ERAS groupProcedure: The ERAS group
- Registration Number
- NCT03517098
- Lead Sponsor
- West China Hospital
- Brief Summary
As the world goes into the aging society, the number of total hip and total knee arthroplasty (THA and TKA) will increase fast. It's important to develop strategies to improve the quality of healthcare and get earlier recovery and better outcome for patients undergoing THA and TKA. Enhanced recovery after surgery (ERAS) pathways have been reported to promote faster recovery in some clinical settings, but most of them are retrospective cohort study. We hypothesized that ERAS pathway could provide better recovery than current routine clinical practice for patients undergoing primary THA or TKA.
This trial is a prospective, open-labelled, randomized controlled trial that will test, for length of stay (LOS) in hospital, the superiority of ERAS pathway as compared with current clinical practice. A total of 604 patients undergoing primary THA or TKA will be randomized to allocate either ERAS pathway (ERAS group) or conventional care according to different participating center (non-ERAS group). The primary outcome is LOS in hospital. Secondary outcomes include Postoperative LOS, all-cause mortality by 30 days after operation, in-hospital complications, mobilization, postoperative pain evaluation, total in-hospital cost, and readmission rate by 30 days after discharge from the hospital.
- Detailed Description
Total joint arthroplasty is a definitive treatment for end-stage osteoarthritis of the hip and knee, which is increased as the world goes into the aging society. It was reported that 0.33 million total hip arthroplasty (THA) and 0.7 million total knee arthroplasty (TKA) were performed in the United States annually, and the demand for the procedures were estimated to 0.57 million and 3.48 million per year in 2030, respectively. It's important to find strategies to improve the quality of healthcare and get earlier recovery and better outcome for patients undergoing THA and TKA, so as to slow the growth of the heavy economic burden associated with the increase of the procedures.
Enhanced recovery after surgery (ERAS) is proposed as a series of evidence-based perioperative optimization with multidisciplinary treatment to reduce surgical stress and accelerate postoperative recovery. Under this general guidelines, different ERAS pathways have been reported to decrease morbidity, save costs, promote faster recovery, and achieve the clinical and economic gain in colorectal, thoracic, and orthopedic surgery. Regional anesthesia was recommended for ERAS because it provides reliable analgesia and little disturbance on hemodynamics in previous literatures. But for patients undergoing THA and TKA, epidural or spinal anesthesia is always associated with indwelling urinary catheter even in surgery with short duration and small amount of blood loss, and femoral or sciatic nerve block decreases muscle strength, leading to postponed mobilization. Nowadays, anesthetic agents with rapid onsetting and clearance make ERAS be applied under general anesthesia. For example, desflurane, a volatile anesthetic with a low blood/gas distribution coefficient, has been reported to metabolized quickly with minor dependence on liver and kidney function, and provide rapid awakening from anesthetic state. Based on its characteristics, we hypothesized that ERAS could be achieved by general anesthesia with the use of short-acting anesthetic agents with the combination of short-acting opioids and muscle relaxant.
In this trial, we'll develop ERAS pathway in patients undergoing primary THA and TKA, and compare with the conventional treatment in length of stay (LOS) in hospital, postoperative complications, as well as the hospitalization costs. The aim of this trial is to verify our hypothesis that ERAS could provide reduced LOS while not increase complications and in-hospital cost when compared with the current clinical practice.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The non-ERAS group The non-ERAS group Patients undergoing THA or TKA will receive conventional care. The ERAS group The ERAS group Patients will be treated with the ERAS pathway
- Primary Outcome Measures
Name Time Method Length of stay (LOS) in hospital 30 days Time from the day on arrival at hospital to discharge from the hospital (unit: days).
- Secondary Outcome Measures
Name Time Method Postoperative LOS 30 days Time from the day of operation to discharge from the hospital (unit: days).
In-hospital complications 30 days after operation Complications after operation
All-cause mortality by 30 days after operation. 30 days after operation All-cause mortality by 30 days after operation.
Mobilization time 30 days after operation Time from the end of operation to ability to walk without human assistance (unit: hours).
Readmission rate 30 days after discharge Readmission rate by 30 days after discharge from the hospital.
Total in-hospital cost. 30 days All cost during hospitalization
Numerical rating scales (NRS) scores at rest and with mobilization or physical therapy 14 days after operation NRS scores will be applied to evaluate the postoperative pain by the patients themselves using a single 11-point numeric rating scale, which is ranged from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain".
Postoperative analgesics requirement. 7 days after operation Postoperative sufentanil or other analgesics requirement.
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China