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
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 effect...
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BMJ Publishing Group
2025-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/5/e095684.full |
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| author | Ryan Paul Atefeh Noori Christian Veillette Darius Luke Lameire Aazad Abbas Jonathan Persitz Heather Baltzer Emily Collett Andrea Chan |
| author_facet | Ryan Paul Atefeh Noori Christian Veillette Darius Luke Lameire Aazad Abbas Jonathan Persitz Heather Baltzer Emily Collett Andrea Chan |
| author_sort | Ryan Paul |
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| description | 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. |
| format | Article |
| id | doaj-art-4be029b962cc4fb6800a7e5dc96d19a7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4be029b962cc4fb6800a7e5dc96d19a72025-08-20T03:47:31ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-095684The 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 studyRyan Paul0Atefeh Noori1Christian Veillette2Darius Luke Lameire3Aazad Abbas4Jonathan Persitz5Heather Baltzer6Emily Collett7Andrea Chan81 Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada2 Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, University Health Network; Toronto Western Hand Program, University of Toronto, Toronto, Ontario, Canada1 Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada1 Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada1 Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada2 Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, University Health Network; Toronto Western Hand Program, University of Toronto, Toronto, Ontario, Canada2 Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, University Health Network; Toronto Western Hand Program, University of Toronto, Toronto, Ontario, Canada4 Schroeder Arthritis Institute & Krembil Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada1 Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, CanadaIntroduction 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.https://bmjopen.bmj.com/content/15/5/e095684.full |
| spellingShingle | Ryan Paul Atefeh Noori Christian Veillette Darius Luke Lameire Aazad Abbas Jonathan Persitz Heather Baltzer Emily Collett Andrea Chan 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/5/e095684.full |
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