Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Surgical field visibility
研究概览
简要总结
This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.
详细描述
Patients undergoing primary arthroscopic rotator cuff repair were randomized in a 1:1 ratio to receive either epinephrine-added irrigation fluid (0.33 mg/L) or an intravenous TXA regimen consisting of a 15 mg/kg bolus administered 10 minutes before surgery followed by a continuous infusion of 10 mg/kg/hour during the procedure. A pressure-controlled arthroscopic pump system was used in all cases according to a standardized protocol. Surgical field visibility was assessed using a 0-10 visual analog scale (VAS). In addition, recorded arthroscopic videos were independently evaluated by a second surgeon who was blinded to treatment allocation. Early postoperative soft-tissue edema was quantified by measuring axillary and deltoid circumferences preoperatively and at 24 hours postoperatively.
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
- Single (Outcomes Assessor)
盲法说明
No additional parties were masked other than the blinded outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •MRI-confirmed full-thickness rotator cuff tear
- •Planned primary arthroscopic rotator cuff repair
- •Written informed consent obtained
排除标准
- •Age >70 years
- •Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease)
- •Significant renal impairment
- •History of thromboembolic disease
- •Contraindication to tranexamic acid
- •Irreparable massive tear with advanced fatty degeneration or severe muscle atrophy
- •Revision surgery
- •Planned concomitant open surgery
研究组 & 干预措施
ARM 1: Epinephrine-Added Irrigation Group
Participants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure.
干预措施: Epinephrine in irrigation fluid (Drug)
ARM2: Intravenous Tranexamic Acid (TXA) Group
Participants received an intravenous tranexamic acid protocol consisting of a 15 mg/kg bolus administered 10 minutes before surgery, followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair.
干预措施: Tranexamic acid, intravenous (Drug)
结局指标
主要结局
Surgical field visibility
时间窗: Intraoperative (during arthroscopic rotator cuff repair)
Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.
次要结局
- Body temperature at 24 hours (°C)(Postoperative 24 hours)
- Mean arthroscopic pump pressure (mmHg)(Intraoperative (during procedure; mean value recorded))
- Total irrigation volume (liters)(Intraoperative (total volume used during procedure))
- Axillary circumference change (cm)(Preoperative and postoperative 24 hours)
- Deltoid circumference change (cm)(Preoperative and postoperative 24 hours)
- Early postoperative complications(Up to 24 hours postoperatively (or during hospitalization))
研究者
ÇAĞRI ÖZCAN
Associate Professor
Saglik Bilimleri Universitesi