Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty

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.

Conditions

• Arthroplasty, Replacement, Hip, Knee

Interventions

PROCEDURE

The 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.

PROCEDURE

The non-ERAS group

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.

Sponsors & Collaborators

• West China Hospital

  lead OTHER

Principal Investigators

• Ren Liao, M.D. · Department of anesthesiology, West China Hospital, Sichuan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2023-01-31

Completion

2023-12-31

Countries

• China

Study Locations