RESUMEN
BACKGROUND: This study compared topical anesthesia to a combination of topical anesthesia and subconjunctival anesthesia for phacoemulsification. METHODS: This double-blinded parallel placebo-controlled randomized trial involved senile cataract patients scheduled for phacoemulsification between May and December 2022. Patients were randomly assigned to receive either topical anesthesia with 0.5% tetracaine hydrochloride and subconjunctival balanced salt solution injection (Control group) or topical anesthesia and subconjunctival injection with 2% lidocaine (Lidocaine group). Baseline parameters, cataract grades, and various outcomes were recorded, including pain scores at specific time points, patient cooperation scores, requests for additional anesthesia, and complications. Statistical methods included Fisher's exact test, the t-test, ordinal logistic regression, and linear regression with robust standard errors. RESULTS: In total, 176 patients were included in the study after excluding 33 patients. A significant reduction in immediate postoperative pain was achieved in the Lidocaine group (p < 0.001) and was maintained for 2 h (p = 0.011). Additionally, better cooperation was observed in this group (p = 0.038). However, patients in the Lidocaine group experienced more pain during the subconjunctival injection (p = 0.001) and a significant increase in subconjunctival hemorrhage related to the injection (p < 0.001). Despite this, the rates of surgical complications were comparable between the groups, and all phacoemulsification procedures were successfully completed using the assigned anesthetic technique. CONCLUSIONS: The addition of subconjunctival lidocaine injection to topical anesthesia reduced postoperative pain and improved patient cooperation during phacoemulsification. However, the lidocaine injection was painful, and it carried a higher risk of spontaneous-relief subconjunctival hemorrhage. TRIAL REGISTRATION: Trial Registration Number: TCTR20220804003, date of registration August 4, 2022, retrospectively registered.