NCT Number: NCT06983886
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Phase 1 / Phase 2
Bangkok, 10400, Thailand
Chanokchon Kongkergkiat, MD
CONTACT
+6622011315 ext. 242
Chanokchon Kongkergkiat, MD
PRINCIPAL_INVESTIGATOR
Kachin Wattanawong, MD, RCST
CONTACT
+6622011315 ext. 242
Kachin Wattanawong, MD, RCST
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 24 hours and 48 hours after the end of intervention
Amount of surgical drain output
Time frame: 24 hours and 48 hours after the end of intervention
Visual analog scale (0-10) 0 = no pain, 10 = the worst pain
Time frame: At 48 hours and 1 week after the end of intervention
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: Intraoperatively
Fromme-Boezaart scale 0 = No bleeding (cadaveric conditions)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=none,1=DVT,2=Stroke,3=MI)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes : urticaria, MP rash, anaphylaxis)
Time frame: within one week after end of the intervention
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes : rash, erythema, itching)
Contact information is provided by the study sponsor or research team.
Chanokchon Kongkergkiat, MD
CONTACT
+6622011315 ext. 242
Kachin Wattanawong, MD, RCST
CONTACT
+6622011315 ext. 242
Ramathibodi Hospital
Other
The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
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