Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial

Joakim Steiness*, Daniel Hägi-Pedersen, Troels H. Lunn, Anders K. Nørskov, Martin Lindberg-Larsen, Ben K. Graungaard, Lars H. Lundstrøm, Peter Lindholm, Stig Brorson, Manuel J. Bieder, Torben Beck, Michael Skettrup, Adam G. von Cappeln, Kasper H. Thybo, Claus Varnum, Lina Pleckaitiene, Niels Anker Pedersen, Søren Overgaard, Ole Mathiesen, Janus C. Jakobsen

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Abstract

Background: The RECIPE trial systematically investigates the effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimise risk of bias and to prevent data-driven analysis, we present this detailed statistical analysis plan. Methods: The RECIPE trial is a randomised, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 h postoperatively. Primary outcome is total opioid consumption 0–24 h after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges–Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind. Discussion: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind67
Udgave nummer3
Sider (fra-til)372-380
ISSN0001-5172
DOI
StatusUdgivet - mar. 2023

Bibliografisk note

Funding Information:
This work was supported by the Novo Nordisk Foundation (grant number NNF19OC0057462) and the Næstved-Slagelse-Ringsted Hospitals' research fund (grant number not applicable). Funders had no role in the writing of this protocol-article, they have no influence on trial conduct and they will have no influence on data analysis or reporting of results.

Funding Information:
This work was supported by the Novo Nordisk Foundation (grant number NNF19OC0057462) and the Næstved‐Slagelse‐Ringsted Hospitals' research fund (grant number not applicable). Funders had no role in the writing of this protocol‐article, they have no influence on trial conduct and they will have no influence on data analysis or reporting of results.

Publisher Copyright:
© 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

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