The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Normal Saline Solution (NSS), Lidocaine (drug).
- Who it may be relevant to
- Registry conditions: Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
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.
Interventions
- Drug 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 mad - Drug 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. - Drug 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) 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 a
Primary outcome measures
- Postoperative blood loss [Time frame: 24 hours and 48 hours after the end of intervention]
Secondary outcome measures (9)
- Postoperative pain score [Time frame: 24 hours and 48 hours after the end of intervention]
- Postoperative edema [Time frame: At 48 hours and 1 week after the end of intervention]
- Surgical filed visibility [Time frame: Intraoperatively]
- Headaches (Adverse events of tranexamic acid) [Time frame: within one week after end of the intervention]
- Nausea vomiting (Adverse events of tranexamic acid) [Time frame: within one week after end of the intervention]
- Seizure (Adverse events of tranexamic acid) [Time frame: within one week after end of the intervention]
- Thromboembolic events (Adverse events of tranexamic acid) [Time frame: within one week after end of the intervention]
- Drug allergy (Adverse events of tranexamic acid) [Time frame: within one week after end of the intervention]
- Local irritation [Time frame: within one week after end of the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Bangkok
Identifiers
NCT: NCT06983886 · MURA2025/288