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

Browse trials for

• Hemorrhage 2,996
• Postoperative Hemorrhage 142

Keywords

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

Study arms

• Active comparator
  Lidocaine with adrenaline and normal saline solution

  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)

• Experimental
  Lidocaine with adrenaline and 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 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

• DrugTranexamic 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 made.

• DrugNormal 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.

• DrugLidocaine (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.

Primary outcomes

1. Postoperative blood loss

   Amount of surgical drain output

   Time frame: 24 hours and 48 hours after the end of intervention

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

Individual participant data

Plan to share: Undecided