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

Arthroplasty, Replacement, Hip, Knee Clinical Trial

Official title:

Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty: a Prospective, Controlled, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517098
• Other study ID #: ERAS180424
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip, Knee

Intervention

Procedure:
• The ERAS group
ERAS pathway for orthopedic surgeons: Shortened preoperative fasting from intake. Preoperative tranexamic acid administration. No indwelling catheters. No tourniquet used for TKA. No drainage tube. Application of the low molecular heparin 6 hours after the operation. ERAS pathway for anesthesiologist: Intravenous 20 mg of dexamethasone before anesthetic induction. Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all. Laryngeal mask for airway. 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. Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied.
• 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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay (LOS) in hospital	Time from the day on arrival at hospital to discharge from the hospital (unit: days).	30 days
Secondary	Postoperative LOS	Time from the day of operation to discharge from the hospital (unit: days).	30 days
Secondary	All-cause mortality by 30 days after operation.	All-cause mortality by 30 days after operation.	30 days after operation
Secondary	In-hospital complications	Complications after operation	30 days after operation
Secondary	Mobilization time	Time from the end of operation to ability to walk without human assistance (unit: hours).	30 days after operation
Secondary	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".	14 days after operation
Secondary	Postoperative analgesics requirement.	Postoperative sufentanil or other analgesics requirement.	7 days after operation
Secondary	Total in-hospital cost.	All cost during hospitalization	30 days
Secondary	Readmission rate	Readmission rate by 30 days after discharge from the hospital.	30 days after discharge