The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250501003

Enrollment

Registered

2025-05-01

Start date

2025-05-12

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative blood loss in patient undergoing orthognathic surgery (bilateral sagittal split ramus osteotomies (BSSRO) using Hunsuck technique, with or without Le Fort I maxillary osteotomy, and without genioplasty) Postoperative blood loss Orthognathic surgery Bilateral sagittal split ramus osteotomies BSSO BSSRO Tranexamic acid

Interventions

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

Active Comparator Drug,Experimental Drug

Lidocaine with adrenaline and normal saline solution,Lidocaine with adrenaline and tranexamic acid

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-50 years undergoing orthognathic surgery with bilateral sagittal split ramus osteotomies (BSSRO), with or without Le Fort I maxillary osteotomy, and without genioplasty. 2. ASA physical status I-II

Exclusion criteria

Exclusion criteria: 1. History of allergy to tranexamic acid 2. History of thromboembolic disorders 3. Use of medications affecting blood coagulation (antiplatelet or anticoagulants) within the past 2 weeks 4. History of cerebrovascular disease 5. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Postoperative blood loss 24 hours and 48 hours after the end of intervention Amount of surgical drain output	—

Secondary

Measure	Time frame
Postoperative pain score 24 hours and 48 hours after the end of intervention visual analog scale (1-10),Postoperative edema At discharge date and postoperative 1 week Standardized frontal facial photographs to determine whether the left side, right side, or both sides were equally swollen. The evaluation was performed by 3 independent assessors.,Surgical filed visibility Intraoperatively Fromme-Boezaart scale,Adverse events of tranexamic acid within one week after end of the intervention Patient reported outcome using a questionnaire interview And clinical examination	—

Measure

Time frame

Postoperative pain score 24 hours and 48 hours after the end of intervention visual analog scale (1-10),Postoperative edema At discharge date and postoperative 1 week Standardized frontal facial photographs to determine whether the left side, right side, or both sides were equally swollen. The evaluation was performed by 3 independent assessors.,Surgical filed visibility Intraoperatively Fromme-Boezaart scale,Adverse events of tranexamic acid within one week after end of the intervention Patient reported outcome using a questionnaire interview And clinical examination

—

Countries

Thailand

Contacts

Public ContactChanokchon Kongkergkiat

Faculty of Medicine Ramathibodi Hospital, Mahidol University

k.chanokchonk@gmail.com022011315

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026