Clinical trial NCT06983886: The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery
Official title: The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery
Keywords: Postoperative blood loss
Orthognathic surgery
Bilateral sagittal split ramus osteotomies
BSSO
BSSRO
Tranexamic acid
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative blood loss
timeFrame: 24 hours and 48 hours after the end of intervention
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 24 hours and 48 hours after the end of intervention
measure: Postoperative edema
timeFrame: At 48 hours and 1 week after the end of intervention
measure: Surgical filed visibility
timeFrame: Intraoperatively
measure: Headaches (Adverse events of tranexamic acid)
timeFrame: within one week after end of the intervention
measure: Nausea vomiting (Adverse events of tranexamic acid)
timeFrame: within one week after end of the intervention
measure: Seizure (Adverse events of tranexamic acid)
timeFrame: within one week after end of the intervention
measure: Thromboembolic events (Adverse events of tranexamic acid)
timeFrame: within one week after end of the intervention
measure: Drug allergy (Adverse events of tranexamic acid)
timeFrame: within one week after end of the intervention
measure: Local irritation
timeFrame: within one week after end of the intervention
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
References: