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.
anaesthetics
pain management
surgery
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
13 08 2021
13 08 2021
Historique:
entrez:
14
8
2021
pubmed:
15
8
2021
medline:
18
8
2021
Statut:
epublish
Résumé
Patients 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. We 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 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.
Identifiants
pubmed: 34389577
pii: bmjopen-2021-049676
doi: 10.1136/bmjopen-2021-049676
pmc: PMC8365802
doi:
Substances chimiques
Analgesics, Opioid
0
Types de publication
Clinical Trial Protocol
Journal Article
Pragmatic Clinical Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e049676Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Anesthesiology. 2013 Jun;118(6):1332-40
pubmed: 23411725
JAMA. 2018 Feb 6;319(5):483-494
pubmed: 29411037
Anesthesiology. 2018 Sep;129(3):590-607
pubmed: 29738328
Br J Anaesth. 2018 Jan;120(1):28-36
pubmed: 29397134
Anesthesiology. 2020 Jun;132(6):1362-1370
pubmed: 32167984
Ann Med. 2001 Jul;33(5):337-43
pubmed: 11491192
BMJ. 2012 Jun 22;344:e4178
pubmed: 22730543
Scand J Pain. 2016 Jul;12:19-24
pubmed: 28850486
J Grad Med Educ. 2013 Dec;5(4):541-2
pubmed: 24454995
Br J Anaesth. 2008 Jul;101(1):77-86
pubmed: 18434337
Bone Joint Res. 2017 Dec;6(12):665-666
pubmed: 29212762
Anesthesiology. 2016 Jul;125(1):39-45
pubmed: 27159009
Pain. 2019 Jan;160(1):45-52
pubmed: 30586070
Qual Life Res. 2018 Jul;27(7):1885-1891
pubmed: 29569016
Anesthesiology. 2012 Feb;116(2):248-73
pubmed: 22227789
Anesthesiology. 2015 Mar;122(3):524-36
pubmed: 25689757
Stat Med. 1990 Jul;9(7):811-8
pubmed: 2218183
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Lancet. 2008 Jul 12;372(9633):139-44
pubmed: 18582931
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
J Pain. 2019 Oct;20(10):1140.e1-1140.e22
pubmed: 30831273
Lancet. 2019 Apr 13;393(10180):1547-1557
pubmed: 30983590
Value Health. 2016 Jun;19(4):343-52
pubmed: 27325326