The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre – The TRADR study
Bibliographic record
Abstract
INTRODUCTION: Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient's satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain. METHODS AND ANALYSIS: The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events. ETHICS AND DISSEMINATION: This study was approved by the University Health Network Research Ethics Board (REB 23-5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment. PROTOCOL VERSION: Version 2.0: August 26, 2024.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.030 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.053 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".