Rationale and design of influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria assessment: study protocol for a prospective randomized controlled trial

Abstract

Background Many patients develop chronic postsurgical pain (CPSP) after cardiac surgery, which interferes with sleep, mood and quality of life. Studies have suggested that propofol improved postoperative analgesia compared with volatile anesthetics, but the prevention effect on CPSP following cardiac surgery is still unknown. This study has been designed to compare the incidence in CPSP following cardiac surgery receiving volatile anesthesia compared to propofol-based total intravenous anesthesia (TIVA) using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) criteria assessment. Methods This is a prospective randomized controlled trial. Five hundred adult patients undergoing cardiac surgery will be randomly allocated to the volatile or the TIVA group. The volatile group will receive sevoflurane or desflurane during surgery to provide general anesthesia. The TIVA group will receive propofol-based intravenous agents and no volatile agents during surgery. The primary outcome will be the frequency of CPSP at 3 months, 6 months and 1 year after surgery. CPSP is defined as two ways: sternal and/or thoracic pain: (1) numeric rating scale, NRS >0; (2) meets all six IMMPACT criteria for CPSP assessed using validated pain instruments. Discussion To our knowledge, this is the first prospective randomized protocol investigating the prevention of CPSP following cardiac surgery receiving volatile anesthesia compared to propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations. This study will provide important information on whether the choice of these two anesthetic regimens might influence CPSP after cardiac surgery. Trial registration: Chictr.org.cn, ID ChiCTR1900020747. Registered on 16 January 2019.