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

ConditionPostoperative Blood Loss in Patient Undergoing Orthognathic Surgery
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorRamathibodi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid

    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.

  • 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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Lidocaine with adrenaline and normal saline solutionActive comparator 2 interventions
Group B: Lidocaine with adrenaline and tranexamic acidExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative blood loss

Amount of surgical drain output

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

Secondary outcomes

1

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
2

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
3

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
4

Headaches (Adverse events of tranexamic acid)

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

Time frame
within one week after end of the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ramathibodi Hospital

Lead sponsor

Source ClinicalTrials.gov

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