Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery
Conditions
Keywords
Postoperative blood loss, Orthognathic surgery, Bilateral sagittal split ramus osteotomies, BSSO, BSSRO, Tranexamic acid
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.
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.
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.
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative blood loss | 24 hours and 48 hours after the end of intervention | Amount of surgical drain output |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | 24 hours and 48 hours after the end of intervention | Visual analog scale (0-10) 0 = no pain, 10 = the worst pain |
| Postoperative edema | 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. |
| Surgical filed visibility | Intraoperatively | 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 |
| Headaches (Adverse events of tranexamic acid) | within one week after end of the intervention | Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes) |
| Drug allergy (Adverse events of tranexamic acid) | 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) |
| Seizure (Adverse events of tranexamic acid) | within one week after end of the intervention | Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes) |
| Thromboembolic events (Adverse events of tranexamic acid) | 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) |
| Local irritation | 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) |
| Nausea vomiting (Adverse events of tranexamic acid) | within one week after end of the intervention | Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes) |
Countries
Thailand
Contacts
Primary ContactChanokchon Kongkergkiat, MD
Backup ContactKachin Wattanawong, MD, RCST
Outcome results
None listed