The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

Study Overview
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Brief Summary
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Tranexamic acid (TXA) is a synthetic inhibitor of plasminogen lysine receptor that has used to reduce intra-operative bleeding in a number of clinical scenarios. Anecdotally, TXA has used by plastic surgeons to reduce post-operative bruising. To date, there is limited data to valid the benefits and to evaluate the side effects of TXA. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Detailed Description
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Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reduce bleeding. Recent studies have demonstrated the antifibrinolytic benefits of TXA in a number of clinical scenarios, including heavy menstrual bleeding, traumatic hemorrhage, elective cesarean section, total knee arthroplasty, coronary artery surgery, spinal deformity surgery, orthognathic surgery, transurethral prostate resection, aneurysmal subarachnoid hemorrhage, epistaxis, and hemoptysis. Anecdotally, TXA has been used by plastic surgeons to reduce postoperative bruising. However, there is a paucity of clinical data on TXA use in plastic surgery, and the results are inconsistent. In a prospective randomized controlled trial evaluating local TXA in upper blepharoplasty, Sagiv et al reported no intraoperative blood loss, surgeon's assessment of hemostasis, and periocular ecchymosis size on postoperative day 1. Butz and Geldner reviewed their experience placing TXA-soaked pledgets in 57 patients who underwent face lift18. They identified only 1 patient who had post-operative hematoma and they reported no systemic complications from TXA use. In a randomized control trial evaluating topical TXA in reduction mammoplasty, Ausen et al reported 39% reduction of postoperative fluid drainage on the treatment side. In a study evaluating oral TXA and cortisone effect in rhinoplasty, Sakalliogu et al reported significant reduction of intraoperative bleeding and postoperative ecchymosis/edema in patients who underwent rhinoplasty. Further study is warranted to evaluate the use to TXA in plastic surgery. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Official Title
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The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

Conditions
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Edema, Ecchymosis; Eyelid

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: Local anesthetic control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old Undergo bilateral upper/lower eyelid blepharoplasty, bilateral upper eyelid ptosis repair, or a combination of the above procedures Additional concurrent forehead/brow or upper/lower eyelids surgeries may be included if bilateral Exclusion Criteria: Prior eyelid surgery Anticoagulant or antiplatelet use, including aspirin, within 7 days prior to surgery Patient who is currently pregnant or breast feeding Patient with color vision deficiency TXA allergy History of bleeding disorder History of clotting disorder History of seizure Have active nausea/vomiting/gastrointestinal symptoms Have active intracranial bleeding Have active periocular ecchymosis or edema prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized control trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid arm<br>Eyelid(s) that received tranexamic acid in the local anesthetic | Drug: Tranexamic acid injection<br>* Tranexamic acid (100 mg/mL concentration; 0.5 mL) will be added to local anesthetic mixture of 2% lidocaine with epinephrine (2.25 mL) and 0.5% bupivacaine with epinephrine (2.25mL).<br>|
| Active Comparator: Control<br>Eyelid(s) that receive local anesthetic without tranexamic acid | Other: Local anesthetic control<br>* Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative edema/ecchymosis | Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising) | 1st post op visit: post-op day 1 to 3 | 
| Post-operative edema/ecchymosis | Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising) | 2nd post op visit: post-op day 7 to 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis | 1st post op visit: post-op day 1 to 3 | 
| Post-operative complications | Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis | 2nd post op visit: post-op day 7 to 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Post-operative ecchymosis, Post-operative edema