A Phase 1/2 interventional study of Tranexamic Acid and Normal Saline Solution (NSS) in Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery, sponsored by Ramathibodi Hospital. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Ramathibodi Hospital · Phase 1/2, Interventional, and Treatment
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.
135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Postoperative blood loss
Amount of surgical drain output
Time frame: 24 hours and 48 hours after the end of intervention
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
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
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
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
Nausea vomiting (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
Seizure (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
Thromboembolic events (Adverse events of tranexamic acid)
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
Drug allergy (Adverse events of tranexamic acid)
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
Local irritation
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes : rash, erythema, itching)
Time frame: within one week after end of the intervention
Plan to share: Undecided
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Start is estimated for May 2025; primary completion for Jun 2026, 13 months later.
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Studies of the drug tested here: Tranexamic Acid
Ramathibodi Hospital