Comparative clinical trial of intracameral ropivacaine vs. lignocaine in subjects undergoing phacoemulsification under augmented topical anesthesia.

ABSTRACT

Purpose: To compare intracameral Ropivacaine to Lignocaine during phacoemulsification under augmented topical anesthesia, in terms of efficacy and safety. Methods: This prospective, randomized, double-masked clinical trial included subjects planned for phacoemulsification with posterior chamber intraocular lens implantation for visually significant uncomplicated senile cataract, under augmented topical anesthesia. Cases were randomized into two groups, Group A (Ropivacaine 0.1%) or Group B (Lignocaine 1.0%). The pain experienced by the patients during the surgery, mydriasis, post-op inflammation and endothelial cell change at six weeks after the procedure was evaluated. Surgeon's feedback was recorded to evaluate the cooperation of the patient during surgery. Results: A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group. There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10). Subjects in Group A fared better when compared to Group B with respect to endothelial cell loss (P = 0.0008), and augmentation in mydriasis (P < 0.001). Conclusion: Intracameral Ropivacaine and Lignocaine, both are equally effective in providing analgesia during phacoemulsification. However, intracameral Ropivacaine is superior to Lignocaine with regards to corneal endothelial cell safety, and augmenting mydriasis.