The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
NCT04951128 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-07-06
Summary
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.
Conditions
- Edema
- Ecchymosis; Eyelid
Interventions
- DRUG
-
Tranexamic acid injection
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).
- OTHER
-
Local anesthetic control
Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).
Sponsors & Collaborators
-
Consultants in Ophthalmic and Facial Plastics Surgery
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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