The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery

Mahidol University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery

Treatments: Drug: Normal Saline Solution (NSS); Drug: Lidocaine (drug); Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06983886

MURA2025/288

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

25 participants in 2 patient groups

Lidocaine with adrenaline and normal saline solution

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine (drug)

Drug: Normal Saline Solution (NSS)

Lidocaine with adrenaline and tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Drug: Lidocaine (drug)