NIPH Clinical Trials Search

A Study on the Optimal Epinephrine Concentration in Blepharoptosis Surgery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Blepharoptosis
Date of first enrollment	07/04/2026
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	The concentration of epinephrine in the local anesthetic was increased to 1:50,000.

Outcome(s)

Primary Outcome

Operative time (minutes) from skin incision to incision of the orbital septum, during which hemostatic procedures are primarily required. Because the amount of bleeding in this procedure is minimal, direct measurement of blood loss was deemed inappropriate as an outcome measure.

Secondary Outcome

Secondary assessment of intraoperative bleeding Surgeon-rated operative field visibility score (Likert scale) The surgeon will comprehensively evaluate the surgical field from skin incision to incision of the orbital septum and record the score according to the following criteria: 1. Excessive bleeding, poor surgical field, and difficult manipulation 2. Moderate bleeding with reduced visibility 3. Some bleeding present but not interfering with the procedure (acceptable) 4. Minimal bleeding with a good surgical field 5. Almost no bleeding with an clear surgical field Total operative time (minutes) Number of bipolar cautery uses (times) Intraoperative parameters Total volume of local anesthetic used (mL) Maximum intraoperative systolic blood pressure (mmHg) Maximum intraoperative heart rate (beats/min) Change in systolic blood pressure (mmHg) from before local anesthesia to 10 minutes after administration Postoperative outcomes Postoperative hematoma (Cases requiring emergency wound reopening, hemostasis, and hematoma evacuation) Number of postoperative analgesic doses (loxoprofen) (times/10 doses) Severity of postoperative subcutaneous hemorrhage (ecchymosis) Evaluated at suture removal (7-14 days postoperatively) using the following 3-point scale 1. Ecchymosis extending beyond the upper eyelid 2. Ecchymosis involving more than half of the upper eyelid 3. Ecchymosis involving less than half of the upper eyelid Rate of undercorrection MRD-1 will be measured using frontal photographs taken immediately after surgery and at 1 month postoperatively, and the difference will be evaluated Presence or absence of reoperation within 6 months postoperatively Collected Patient Background Variables Age Sex Body mass index (BMI) Presence of hypertension Smoking history Presence of diabetes mellitus Use of antithrombotic agents (patients who were able to discontinue medication perioperatively will be included) Performance of lateral horn release Inpatient or outpatient surgery

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients aged 20 years or older. Patients who underwent bilateral blepharoptosis surgery (levator aponeurosis advancement).
Exclude criteria	Patients under 20 years of age. Patients who underwent unilateral surgery only. Patients who underwent blepharoptosis surgery using procedures other than levator aponeurosis advancement. Patients who had previously undergone blepharoptosis surgery at our institution or another institution and underwent the current procedure as a revision surgery. Patients diagnosed with congenital blepharoptosis. Patients with suspected underlying conditions such as myasthenia gravis, facial nerve palsy, or Horner syndrome. Patients receiving antithrombotic therapy who were unable to discontinue the medication during the perioperative period. Patients with thrombocytopenia (below the institutional reference range) or coagulation abnormalities due to other diseases.