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

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 sta...

Full description

Saved in:
Bibliographic Details
Published in:Acta anaesthesiologica Scandinavica 2023-03, Vol.67 (3), p.372-380
Main Authors: Steiness, Joakim, Hägi‐Pedersen, Daniel, Lunn, Troels H., Nørskov, Anders K., Lindberg‐Larsen, Martin, Graungaard, Ben K., Lundstrøm, Lars H., Lindholm, Peter, Brorson, Stig, Bieder, Manuel J., Beck, Torben, Skettrup, Michael, Cappeln, Adam G., Thybo, Kasper H., Varnum, Claus, Pleckaitiene, Lina, Anker Pedersen, Niels, Overgaard, Søren, Mathiesen, Ole, Jakobsen, Janus C.
Format: Article
Language:English
Subjects:
Acetaminophen - therapeutic use
anaesthesiology
Analgesics
Analgesics, Non-Narcotic - therapeutic use
Analgesics, Opioid - therapeutic use
Arthroplasty, Replacement, Hip
Biomedical materials
Clinical trials
Confidence intervals
Data analysis
Dexamethasone
glucocorticoid
Hip
Humans
Ibuprofen - therapeutic use
Joint replacement surgery
multimodal analgesia
Narcotics
NSAID
Opioids
Orthopaedic implants
Pain
Pain, Postoperative - drug therapy
Pain, Postoperative - prevention & control
Paracetamol
Patients
Statistical analysis
Statistics
Total hip arthroplasty
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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
ISSN:0001-5172
1399-6576
DOI:10.1111/aas.14179