Postoperative Blood Loss in Patient Undergoing Orthognathic SurgeryPhase 1/2NCT06983886
The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery
A Phase 1/2 study testing Tranexamic Acid, Normal Saline Solution (NSS) and Lidocaine (drug) in people with Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery
- What is being tested?
- Tranexamic Acid, Normal Saline Solution (NSS) and Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- 12 May 2025to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, 10400
Chanokchon Kongkergkiat, MD, +6622011315 ext. 242, k.chanokchonk@gmail.com
Kachin Wattanawong, MD, RCST, +6622011315 ext. 242, doctor007@hotmail.com
About this study
Official title: The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
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.
- Being tested
- Tranexamic Acid, Normal Saline Solution (NSS), Lidocaine (drug)
- Keywords
- Postoperative blood loss, Orthognathic surgery, Bilateral sagittal split ramus osteotomies, BSSO, BSSRO, Tranexamic acid
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Normal Saline Solution (NSS); Drug: Lidocaine (drug) |
| 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. Receives: Drug: Tranexamic Acid; Drug: Lidocaine (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood loss
Amount of surgical drain output
Measured: 24 hours and 48 hours after the end of intervention
Secondary outcomes (9)
Postoperative pain score
Visual analog scale (0-10) 0 = no pain, 10 = the worst pain
Measured: 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.
Measured: At 48 hours and 1 week after the end of intervention
Surgical filed visibility
Fromme-Boezaart scale 0 = No bleeding (cadaveric conditions)
- = Slight bleeding - no suction required
- = Slight bleeding - occasional suctioning required
- = Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed
- = Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed
- = Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely
Measured: Intraoperatively
Headaches (Adverse events of tranexamic acid)
Patient reported outcome using a questionnaire interview And clinical examination (0=no,1=yes)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within one week after end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 May 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Blood Loss in Patient Undergoing Orthognathic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanokchon Kongkergkiat, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983886
- Sponsor's protocol ID
- MURA2025/288
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06983886
- Acronym / sponsor ID
- MURA2025/288
- Keywords
- Postoperative blood loss, Orthognathic surgery, Bilateral sagittal split ramus osteotomies, BSSO, BSSRO, Tranexamic acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine with adrenaline and normal saline solution | Active comparator | 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 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. |
| Lidocaine with adrenaline and tranexamic acid | Experimental | 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. 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidA 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. | Drug | Lidocaine with adrenaline and tranexamic acid |
| Normal 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. | Drug | Lidocaine with adrenaline and normal saline solution |
| Lidocaine (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. | Drug | Lidocaine with adrenaline and normal saline solution, Lidocaine with adrenaline and tranexamic acid |
Primary outcome
Postoperative blood loss
Time frame: 24 hours and 48 hours after the end of intervention
Amount of surgical drain output
9 secondary outcomes
Postoperative pain score
Time frame: 24 hours and 48 hours after the end of intervention
Postoperative edema
Time frame: At 48 hours and 1 week after the end of intervention
Surgical filed visibility
Time frame: Intraoperatively
Headaches (Adverse events of tranexamic acid)
Time frame: within one week after end of the intervention
Nausea vomiting (Adverse events of tranexamic acid)
Time frame: within one week after end of the intervention
Seizure (Adverse events of tranexamic acid)
Time frame: within one week after end of the intervention
Thromboembolic events (Adverse events of tranexamic acid)
Time frame: within one week after end of the intervention
Drug allergy (Adverse events of tranexamic acid)
Time frame: within one week after end of the intervention
Local irritation
Time frame: within one week after end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid, Normal Saline Solution (NSS) and Lidocaine (drug) in people with Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chanokchon Kongkergkiat, MD (+6622011315 ext. 242, k.chanokchonk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative blood loss (time frame: 24 hours and 48 hours after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.