Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery

• Published in: BMJ open Vol. 11; no. 8; p. e049676
• Main Authors: Admiraal, Manouk, Hermanns, Henning, Hermanides, Jeroen, Wensing, Carin G.C.L., Meinsma, Soe L., Wartenberg, Hans C. H., Rutten, Martin V. H., Ward - van der Stam, Vivian M. C., Hollmann, Markus W.
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 13.08.2021; BMJ Publishing Group
• Series: Protocol
• Subjects: Anaesthesia; Analgesics, Opioid - therapeutic use; Catheters; Epidural; Hospitals; Humans; Informed consent; Medical records; Medical referrals; Medical screening; Narcotics; Ostomy; Pain Management; Pain, Postoperative - drug therapy; Pain, Postoperative - prevention & control; Patients; Pragmatic Clinical Trials as Topic; Quality standards; Recruitment; Severe acute respiratory syndrome coronavirus 2; Spinal cord; Standard of Care; Surgeons; Surgery; Trust; Netherlands; pain management; anaesthetics; surgery
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-049676

IntroductionPatients with either surgery-related or patient-related risk factors are at an increased risk of acute and chronic postsurgical pain (CPSP) and long-term opioid use. To improve recovery, prevent CPSP and decrease opioid use, we need to identify these patients before surgery and provide a multidisciplinary pain management strategy throughout hospital admission and follow-up in the postdischarge period. We hypothesise that a multidisciplinary transitional pain service (TPS) improves quality of recovery and reduce the incidence of CPSP and opioid consumption.Methods and analysisWe aim to investigate the effectiveness of implementation of a TPS for patients at risk of developing CPSP. The trial design is a pragmatic, open-label, randomised controlled trial (RCT). After stratification for sex, patients are randomly assigned to the TPS or standard of care (SOC) group. Our primary outcome is the quality of recovery, measured at the morning of the third postoperative day, employing the quality of recovery (QoR)-15 questionnaire. Secondary outcomes are the incidence of CPSP, opioid consumption and patient-reported outcome measures at 3 and 6 months postoperatively. We need to enrol 176 patients to detect a minimal clinical important difference of 8 points on the QoR-15 score.Ethics and disseminationEthics approval was obtained by the accredited medical research ethics committee of the Academic Medical Center in Amsterdam (2020_211) on 15 October 2020. Protocol version 3.2 was approved on 25 January 2020. The trial is registered with the Netherlands Trial Register, NL9115. The results will be disseminated by open access publication in a peer-reviewed journal.Trial registration number NL9115