Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

INTRODUCTION: Total knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regimen and assess the effect of a tourniquet on the patient's recovery following total knee arthroplasty.

METHODS AND ANALYSIS: This study is a randomised, controlled, parallel-group, four-arm study comparing spinal and general anaesthesia with and without a tourniquet in 400 patients undergoing fast-track total knee arthroplasty, with a 12-month follow-up. The primary outcome is cumulative intravenous oxycodone consumption by patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative nausea and vomiting, the length of hospital stay, the duration of the surgery, blood loss, demand for surgical unit resources, complications, readmissions, postoperative knee function, range of motion, health-related quality of life, prolonged pain and mortality.

ETHICS AND DISSEMINATION: This study's protocol is in accordance with the declaration of Helsinki. The results of this study will be disseminated in international peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT03364088; Pre-results.