An interventional study of The ERAS group and The non-ERAS group in Arthroplasty, Replacement, Hip, Knee, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by West China Hospital · Not applicable, Interventional, and Treatment
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.
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.
West China Hospital is the lead sponsor of 484 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Patients will be treated with the ERAS pathway
Procedure: The ERAS group
Patients undergoing THA or TKA will receive conventional care.
Procedure: The non-ERAS group
ERAS pathway for orthopedic surgeons: 1. Shortened preoperative fasting from intake. 2. Preoperative tranexamic acid administration. 3. No indwelling catheters. 4. No tourniquet used for TKA. 5. No drainage tube. 6. Application of the low molecular heparin 6 hours after the operation. ERAS pathway for anesthesiologist: 1. Intravenous 20 mg of dexamethasone before anesthetic induction. 2. Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all. 3. Laryngeal mask for airway. 4. Anesthesia will be maintained with short-acting anesthetic agents such as desflurane, sevoflurane, or propofol, with continuous remifentanil , and BIS value will be kept between 40 to 60 during procedure. 5. Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied.
Patients undergoing THA or TKA will receive conventional care according to different participating center, and there's no standard protocol for pre-operative management, anesthetic technique or medication choice, postoperative analgesia or food intake, or catheters indwelling.
Length of stay (LOS) in hospital
Time from the day on arrival at hospital to discharge from the hospital (unit: days).
Time frame: 30 days
Postoperative LOS
Time from the day of operation to discharge from the hospital (unit: days).
Time frame: 30 days
All-cause mortality by 30 days after operation.
All-cause mortality by 30 days after operation.
Time frame: 30 days after operation
In-hospital complications
Complications after operation
Time frame: 30 days after operation
Mobilization time
Time from the end of operation to ability to walk without human assistance (unit: hours).
Time frame: 30 days after operation
Numerical rating scales (NRS) scores at rest and with mobilization or physical therapy
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".
Time frame: 14 days after operation
Postoperative analgesics requirement.
Postoperative sufentanil or other analgesics requirement.
Time frame: 7 days after operation
Total in-hospital cost.
All cost during hospitalization
Time frame: 30 days
Readmission rate
Readmission rate by 30 days after discharge from the hospital.
Time frame: 30 days after discharge
Plan to share: Yes — Individual participant data will be accessed under request to Dr. Ren Liao by email: liaoren7733@163.com.
Supporting information: Study protocol
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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