Clinical Trial Comparing Intracameral Ropivacaine Vs. Lignocaine For Phacoemulsification Under Augmented Topical Anesthesia

The goal of this study was to assess the efficacy and safety of Intracameral Ropivacaine vs Lignocaine during Phacoemulsification under Augmented Topical Anaesthesia.

In a tertiary care government hospital in Northern India, this was a double-blind, randomised control trial to compare the pain experienced by the patient, surgeon's experience and the surgical outcomes of cataract surgery under augmented topical anaesthesia using Ropivacaine vs Lignocaine.  Institutional Review Board permission was taken and Tenants of the Declaration of Helsinki were adhered to.

This was a prospective, randomized, double-masked clinical trial wherein subjects planned for phacoemulsification with posterior chamber intraocular lens implantation for visually significant uncomplicated senile cataract under augmented topical anesthesia were included. Randomization was done into two groups,  Group A (Ropivacaine 0.1%) or Group B (Lignocaine 1.0%). Outcomes evaluated were pain experienced during the surgical procedure,  mydriasis, post-operative inflammation, and change in endothelial cell count at six weeks. For the purpose of evaluating the patient's compliance during surgery, the surgeon's feedback was recorded.

A total of 210 subjects were screened. Of these, 184 subjects were included in the study and randomized into groups of two with 92 subjects in each. On comparing both the groups, no statistical difference was seen 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). There was a statistically significant difference in endothelial cell loss (P = 0.0008), and augmentation in mydriasis (P < 0.001) in Group A and B where Group A showed better results.

Intracameral Ropivacaine when compared to Lignocaine in providing analgesia, proved equally effective. Ropivacaine was superior to Lignocaine in maintaining mydriasis and safety of endothelial cells. This makes Ropivacaine a preferable choice for intracameral use as anesthetic agent.