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DEX-2-TKA - DEXamethasone twice for pain treatment after total knee arthroplasty. Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial

Acta Anaesthesiologica Scandinavica Feb 19, 2020

Gasbjerg KS, Hägi-Pedersen D, Lunn TH, et al. - Researchers sought to perform the ‘DEXamethasone twice for pain treatment after TKA’ trial, a randomized, blinded, three-group multicentre clinical trial, with the aim to determine the role of one or two doses of glucocorticoid for postoperative pain treatment after total knee arthroplasty. They published this article with a detailed statistical analysis plan before the last participant is enrolled in order to assure transparency and minimization of bias. Randomization of participants will be done to one of three intervention groups: a single dose of intravenous dexamethasone 24 mg, two consecutive doses of intravenous 24 mg dexamethasone, or matching intravenous placebo. Paracetamol, ibuprofen, and local infiltration analgesia will be provided to all three intervention groups. The allocated intervention will not be revealed to participants, treatment providers, outcome assessors, data managers, statisticians, and conclusion drawers. Total opioid consumption (intravenous morphine milligram equivalents) 0-48 hours postoperatively will be assessed as the primary outcome. They will assess following as secondary outcomes: 1) visual analog scale pain levels: a) during active 45 degrees flexion of the knee at 24 and 48 hours postoperatively, b) at rest at 24 and 48 hours postoperatively, and c) during 0-24 hours (highest score) and 24-48 hours postoperatively (highest score); and 2) the proportion of participants with one or more adverse events within 48 hours postoperatively. It is expected that high-quality data concerning benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen will be accomplished by the DEX-2-TKA trial.
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