The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Postoperative blood loss
研究概览
简要总结
The effect of local infiltration of tranexamic acid in orthognathic surgery remains unclear. This study was conducted to evaluate the difference in postoperative blood loss, measured by surgical drain output, following orthognathic surgery. The investigation involved a within-subject comparison, where each side of the mandible received a different local anesthetic solution: one side was infiltrated with a mixture of lidocaine with adrenaline and tranexamic acid, while the other side received lidocaine with adrenaline and normal saline.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-50 years
- •undergoing orthognathic surgery (Bilateral sagittal split ramus osteotomies (BSSRO), with or without Le Fort I maxillary osteotomy)
- •ASA physical status I-II
排除标准
- •Genioplasty in the operation
- •History of allergy to tranexamic acid
- •History of thromboembolic disorders
- •Use of medications affecting blood coagulation (antiplatelet or anticoagulants) within the past 2 weeks
- •History of cerebrovascular disease
- •Pregnant or breastfeeding women
研究组 & 干预措施
Lidocaine with adrenaline and normal saline solution
A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of normal saline (NSS), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after the induction of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before making the surgical incision.
This solution will be used on either left or right side of mandible depends on the randomized result, and the other side will be given the solution of another arm.
干预措施: Normal Saline Solution (NSS) (Drug)
Lidocaine with adrenaline and normal saline solution
A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of normal saline (NSS), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after the induction of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before making the surgical incision.
This solution will be used on either left or right side of mandible depends on the randomized result, and the other side will be given the solution of another arm.
干预措施: Lidocaine (drug) (Drug)
Lidocaine with adrenaline and tranexamic acid
A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of tranexamic acid (50 mg/ml), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after completion of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before the surgical incision was made.
This solution will be used on either left or right side of mandible depends on the randomized result, and the other side will be given the solution of another arm.
干预措施: Tranexamic Acid (Drug)
Lidocaine with adrenaline and tranexamic acid
A local anesthetic solution was prepared by mixing 10 ml of 1% lidocaine with adrenaline (1:100,000) and 5 ml of tranexamic acid (50 mg/ml), resulting in a total volume of 15 ml. The solution was injected at the planned mandibular osteotomy sites on both the medial and lateral aspects of the ramus of the mandible. The injection was administered after completion of general anesthesia, followed by a 5-minute waiting period to allow the anesthetic to take effect before the surgical incision was made.
This solution will be used on either left or right side of mandible depends on the randomized result, and the other side will be given the solution of another arm.
干预措施: Lidocaine (drug) (Drug)
结局指标
主要结局
Postoperative blood loss
时间窗: 24 hours and 48 hours after the end of intervention
Amount of surgical drain output
次要结局
- Postoperative edema(At 48 hours and 1 week after the end of intervention)
- Surgical filed visibility(Intraoperatively)
- Nausea vomiting (Adverse events of tranexamic acid)(within one week after end of the intervention)
- Seizure (Adverse events of tranexamic acid)(within one week after end of the intervention)
- Thromboembolic events (Adverse events of tranexamic acid)(within one week after end of the intervention)
- Drug allergy (Adverse events of tranexamic acid)(within one week after end of the intervention)
- Postoperative pain score(24 hours and 48 hours after the end of intervention)
- Headaches (Adverse events of tranexamic acid)(within one week after end of the intervention)
- Local irritation(within one week after end of the intervention)
研究者
Chanokchon Kongkergkiat
Chanokchon Kongkergkiat, M.D.
Ramathibodi Hospital