Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Pain intensity at rest is recorded with the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). The area under the curve (AUC) for these scores will be calculated with the trapezoidal rule, using assessments performed in the PACU and at 1 , 2 , 4 and 6 hours post-operatively. A higher AUC indicates greater cumulative pain over the 6-hour period.

Participants rate their pain intensity at rest and again during voluntary eye movement using the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). Assessments are performed in the PACU and at 1, 2, 4, 6, 12, 24 hours, 1 week, and 1 month post-operatively. Higher scores indicate greater pain.

The area under the curve (AUC) is computed with the trapezoidal rule, multiplying the average Numeric Rating Scale within each interval by its duration and summing the products; a higher AUC indicates greater cumulative pain.

In-hospital, participants with resting NRS ≥4 will receive intravenous flurbiprofen axetil 1 mg/kg. Additional doses can be given if ≥3 hours have passed since the previous flurbiprofen dose and ≥1 hour since the last study drug. Breakthrough pain (NRS ≥7) may be treated immediately. Out-of-hospital, participants with resting NRS ≥4 will receive paracetamol 500 mg per dose, up to 2 g per day.

During the 6-, 12-, and 24-hour postoperative periods, each patient's use of rescue analgesics (flurbiprofen axetil or paracetamol) is recorded. Patients not receiving rescue analgesics are classified as 'not used,' and the percentage is calculated for each group to evaluate postoperative analgesia adequacy.

A trained study assistant assessed satisfaction score of analgesia at rest using a 0 to 10 NRS scale, where 0 indicates 'completely dissatisfied' and 10 indicates 'completely satisfied.'

Emergence time is defined as the interval from stopping anesthetics to eye opening or following simple commands.

PACU stay time is defined as the duration from arrival in PACU to the time of a modified Aldrete score of 9 or 10.

Time to first ambulation is defined as the interval from the completion of surgery to the patient's first episode of spontaneous mobilization (i.e., getting out of bed and initiating independent movement).

Postoperative hospital stay (or in-hospital stay for day-surgery patients) is defined as the interval from the completion of surgery to formal discharge from the hospital.

All assessments of adverse events and medication records will be conducted under double-blind conditions, with evaluators blinded to participant group assignment. The incidence of adverse events will be calculated based on the total number of enrolled participants in each group.

Postoperative recovery was assessed using the QoR-15 questionnaire.

Measured with non-contact tonometer; higher values indicate elevated IOP.

Graded by single examiner via digital palpation.

Assessed with standard LogMAR chart; lower LogMAR indicates better acuity.

Assessed with standard LogMAR chart after refraction; lower LogMAR indicates better acuity.

Quantitative assessment around the periocular area of the operative eye using electronic Von Frey test.