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

NCT06983886 | Not Yet Recruiting Phase 1

• 1 other identifier: MURA2025/288
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery

Keywords

Postoperative blood loss; Orthognathic surgery; Bilateral sagittal split ramus osteotomies; BSSO; BSSRO; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Postoperative blood loss

  Amount of surgical drain output

  24 hours and 48 hours after the end of intervention

Secondary Outcomes (9)

• Postoperative pain score

  24 hours and 48 hours after the end of intervention

• Postoperative edema

  At 48 hours and 1 week after the end of intervention

• Surgical filed visibility

  Intraoperatively

• Headaches (Adverse events of tranexamic acid)

  within one week after end of the intervention

• Nausea vomiting (Adverse events of tranexamic acid)

  within one week after end of the intervention

Study Arms (2)

Lidocaine with adrenaline and normal saline solution

ACTIVE COMPARATOR

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.

Drug: Normal Saline Solution (NSS); Drug: Lidocaine (drug)

Lidocaine with adrenaline and tranexamic acid

EXPERIMENTAL

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.

Drug: Tranexamic Acid; Drug: Lidocaine (drug)

Interventions

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.

Lidocaine with adrenaline and tranexamic acid

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 with adrenaline and normal saline solution

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.

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid; Saline Solution; Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Chanokchon Kongkergkiat, MD

CONTACT

+6622011315; k.chanokchonk@gmail.com

Kachin Wattanawong, MD, RCST

CONTACT

+6622011315; doctor007@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chanokchon Kongkergkiat, M.D.

Model Details: Randomization will be performed using a computer-generated sequence by a research staff member from the Department of Surgery to determine the side of intervention. For example, if the randomized value is 0, the left side will receive the intervention drug and the right side will serve as the control; if the value is 1, the right side will receive the intervention drug and the left side will serve as the control. Block randomization will be used to ensure balanced allocation between the two groups. The randomization result will be sealed in an opaque envelope, which will be opened in the operating room prior to surgery by a resident not involved in the surgical procedure. The envelope will contain the randomization assignment and instructions for drug preparation. This uninvolved resident will prepare two syringes labeled for the left (L) and right (R) sides accordingly. The randomization assignment will remain blinded to the subject, surgical team, evaluator.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 21, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

TH (1)