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

Phase 2Not Yet RecruitingNCT06983886

Ramathibodi Hospital25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery

Interventions

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.

Normal Saline Solution (NSS)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.

Lidocaine (drug)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) or 5 ml of tranexamic acid (50 mg/ml) depends on allocated group, 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative blood loss

Amount of surgical drain output

Time frame: 24 hours and 48 hours after the end of intervention

Secondary Outcomes

Postoperative pain score

Visual analog scale (0-10) 0 = no pain, 10 = the worst pain

Time frame: 24 hours and 48 hours after the end of intervention

Postoperative edema

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.

Time frame: At 48 hours and 1 week after the end of intervention

Surgical filed visibility

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

Time frame: Intraoperatively

Headaches (Adverse events of tranexamic acid)

Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)