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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine with adrenaline and normal saline solution | Active Comparator | 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. |
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| Lidocaine with adrenaline and tranexamic acid | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative blood loss | Amount of surgical drain output | 24 hours and 48 hours after the end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Visual analog scale (0-10) 0 = no pain, 10 = the worst pain | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chanokchon Kongkergkiat, MD | Contact | +6622011315 | 242 | k.chanokchonk@gmail.com |
| Kachin Wattanawong, MD, RCST | Contact | +6622011315 | 242 | doctor007@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Bangkok | Bangkok | 10400 | Thailand |
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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.
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|
| Normal Saline Solution (NSS) | 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), 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. |
|
| Lidocaine (drug) | 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. |
|
| At 48 hours and 1 week after the end of intervention |
| Surgical filed visibility | Fromme-Boezaart scale 0 = No bleeding (cadaveric conditions)
| Intraoperatively |
| Headaches (Adverse events of tranexamic acid) | Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes) | 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) | 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) | 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) | 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) | 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) | within one week after end of the intervention |
| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| D008012 | Lidocaine |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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