Clinical trial NCT03517098: Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty
Official title: Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty: a Prospective, Controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip, Knee
Keywords: Enhanced recovery after surgery
General anesthesia
Total hip arthroplasty
Total knee arthroplasty
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

* Patients undergoing primary TKA and THA, with both genders.
* Aged more than 18 years.
* Ability to communicate. Exclusion criteria
* Refuse to sign consent.
* Pregnancy or lactating woman
* History or family history of malignant hyperthermia.
* Known allergy to desflurane or any other anesthetic agent.
* History of substance abuse.
* History of postoperative delirium.
* Impairment of cognitive function or communication.
* Psychopathy.
* Active participation in another trial where the primary endpoint follow-up is ongoing.
* Unwillingness or inability to comply with protocol procedures.

Primary outcomes:
measure: Length of stay (LOS) in hospital
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative LOS
timeFrame: 30 days
measure: All-cause mortality by 30 days after operation.
timeFrame: 30 days after operation
measure: In-hospital complications
timeFrame: 30 days after operation
measure: Mobilization time
timeFrame: 30 days after operation
measure: Numerical rating scales (NRS) scores at rest and with mobilization or physical therapy
timeFrame: 14 days after operation
measure: Postoperative analgesics requirement.
timeFrame: 7 days after operation
measure: Total in-hospital cost.
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Department of anesthesiology, West China Hospital, Sichuan University
name: Ren Liao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Zhu H, Liao R. Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2019 Oct 22;20(1):599. doi: 10.1186/s13063-019-3706-8.