NCT06384456招募中4 期
The Effect of Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - The TRADR Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- acute post-op pain
研究概览
简要总结
The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
- •Aged 18 or older;
- •Provision of informed consent;
- •Cognitive ability and English-language skills required to complete outcome measures.
排除标准
- •Revision surgery or any additional operative management of ipsilateral wrist injury
- •Distal radius fracture treated with a dorsal approach
- •Known history of lymphedema or lymph node dissection in the operative extremity
- •Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
- •Current user of opioids and/or on chronic opioids use
- •Known allergic reaction to TXA
- •Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)
- •Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)
- •Current pregnancy or breastfeeding
- •Previous neurologic injury causing paralysis of affected shoulder/arm
- •Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).
研究组 & 干预措施
Placebo
Placebo Comparator
10mL of 100mg/mL normal saline in addition to the standard care
干预措施: Placebo (Drug)
Topical TRanexamic Acid
Experimental
10mL of 100mg/mL TXA in addition to the standard care
干预措施: Topical TRanexamic Acid (Drug)
结局指标
主要结局
acute post-op pain
时间窗: 24 hours to 72 hours postoperatively
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
次要结局
- persistent pain(1, 2, and 6-week post-surgery)
- opioid use(1, 2, and 6-week post-surgery)
- Patient reported function(1, 2, and 6-week post-surgery)
- unscheduled hand-related procedures(1, 2, and 6-week post-surgery)
研究者
Ryan Paul
Dr.
University Health Network, Toronto
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Topical Tranexamic Acid Application in RhinoplastyEdemaRhinoplastyEyelid EcchymosisNCT05326139Baskent University50
已完成
3 期
Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKABlood LossNCT01881568Hospital Universitario La Paz79
已完成
早期 1 期
Combined IV and Topical TXA in Major Spine SurgerySpine SurgeryBack PainNCT04797156Icahn School of Medicine at Mount Sinai65
已完成
4 期
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip HemiarthroplastyFemoral Neck FracturesNCT02664909UConn Health36
尚未招募
4 期
Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis ManagementEpistaxis NosebleedNCT06490653Ankara Ataturk Sanatorium Training and Research Hospital186