Kasper S Gasbjerg1, Daniel Hägi-Pedersen1,2, Troels H Lunn3,4, Søren Overgaard5,6, Niels Anker Pedersen7, Jens Bagger8, Peter Lindholm9, Stig Brorson4,10, Henrik M Schrøder6,11, Kasper H Thybo3, Ole Mathiesen4,12, Janus C Jakobsen2,13. 1. Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark. 2. Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 3. Department of Anaesthesiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark. 4. Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark. 5. Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. 6. Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 7. Department of Anaesthesia, Gildhøj Private Hospital, Brøndby, Denmark. 8. Department of Orthopaedics, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark. 9. Department of Anaesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark. 10. Department of Orthopaedic Surgery, Zealand University Hospital, Køge, Denmark. 11. Department of Orthopaedic Surgery, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark. 12. Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark. 13. Department of Cardiology, Holbaek Hospital, Holbaek, Denmark.
Abstract
BACKGROUND: Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the "DEXamethasonetwice for pain treatment after TKA" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled. METHODS: "DEXamethasonetwice for pain treatment after TKA" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively. DISCUSSION: The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen. TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).
RCT Entities:
BACKGROUND: Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the "DEXamethasone twice for pain treatment after TKA" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled. METHODS: "DEXamethasone twice for pain treatment after TKA" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and 48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively. DISCUSSION: The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen. TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).