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

Phase 1

Not yet recruiting

• Conditions: Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery
• Interventions: Drug: Normal Saline Solution (NSS); Drug: Tranexamic Acid; Drug: Lidocaine (drug)

• Registration Number: NCT06983886
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study Start: 2025-05-12
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine with adrenaline and normal saline solution	Normal Saline Solution (NSS)	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.
Lidocaine with adrenaline and tranexamic acid	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.
Lidocaine with adrenaline and normal saline solution	Lidocaine (drug)	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.
Lidocaine with adrenaline and tranexamic acid	Lidocaine (drug)	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.

Primary Outcome Measures

Name	Time	Method
Postoperative blood loss	24 hours and 48 hours after the end of intervention	Amount of surgical drain output

Secondary Outcome Measures

Name	Time	Method
Postoperative edema	At 48 hours and 1 week after the end of intervention	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 0 = No bleeding (cadaveric conditions); 1. = Slight bleeding - no suction required; 2. = Slight bleeding - occasional suctioning required; 3. = Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed; 4. = Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed; 5. = Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely
Nausea vomiting (Adverse events of tranexamic acid)	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Seizure (Adverse events of tranexamic acid)	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Thromboembolic events (Adverse events of tranexamic acid)	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=none,1=DVT,2=Stroke,3=MI)
Drug allergy (Adverse events of tranexamic acid)	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes : urticaria, MP rash, anaphylaxis)
Postoperative pain score	24 hours and 48 hours after the end of intervention	Visual analog scale (0-10) 0 = no pain, 10 = the worst pain
Headaches (Adverse events of tranexamic acid)	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Local irritation	within one week after end of the intervention	Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes : rash, erythema, itching)

Trial Locations

Locations (1)

Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand