Topical EMLA Cream as Adjunct Analgesia in Postoperative Pain Control for Open Inguinal Hernioplasty Under Local Anesthesia: A Pilot Double-Blind Randomized Controlled Trial.

Abstract

Effective postoperative pain control is essential in ambulatory hernia surgery. This pilot randomized controlled trial aimed to evaluate the efficacy, safety, and feasibility of topical EMLA (eutectic mixture of local anesthetics) cream as adjunct postoperative analgesia following open inguinal hernioplasty under local anesthesia. A prospective, double-blind, randomized controlled trial was conducted at Hospital Canselor Tuanku Muhriz, UKM, from December 2023 to March 2025. Thirty-six male patients undergoing elective open inguinal hernia repair under local anesthesia were randomized to receive either EMLA (n = 18) or placebo cream (n = 18). The cream was applied topically to the surgical site every 6 h for 48 h. Pain was self-assessed using a numerical rating scale (NRS) after each application. Primary outcomes included pain scores and rescue analgesia use; secondary outcomes included feasibility and adverse events. Topical application was rated "easy" or "very easy" by all participants, with no adverse events or complications reported. In the EMLA group, pain scores significantly decreased across all post-application time points compared to baseline (p < 0.05), whereas no significant changes were observed in the placebo group. Between-group analysis showed significantly lower pain scores in the EMLA group starting from 6 h postoperatively (p < 0.001). No participants in either group required rescue analgesia. Topical EMLA cream is a feasible adjunct for postoperative pain control following open inguinal hernia repair under local anesthesia. Although no infections or adverse events occurred in this pilot cohort, the study is underpowered to detect rare complications such as surgical site infection; therefore, safety conclusions should be interpreted with caution. The clinically meaningful reduction of 2-3 points in pain scores supports further validation in larger, adequately powered trials using an inert placebo.