AIM: To assess the efficacy and safety of an intraoperative intracameral injection of mepivacaine, administered when patients experienced pain during the course of cataract surgery under topical anaesthesia. METHODS: This is a prospective placebo controlled double masked randomised clinical trial. 50 eyes were included; 25 receiving the active compound and 25 receivingplacebo. Mepivacaine (2%, 0.4 ml) or placebo was administered intraoperatively under the iris of the patients who experienced pain during the course of phacoemulsification in spite of previous topical anaesthesia. Efficacy was evaluated by the patients themselves using a five point subjective pain rating scale, the Keele verbal pain chart. Safety was measured by assessing intraocular inflammation (clinical evaluation and laser flare meter), intraocular pressure, and endothelial cell count. RESULTS: The pain rating score significantly diminished after intracameral injection in the mepivacaine group (mean 3.0 (95% CI 2.6-3.4) v 0.8 (0.3-1.3), p<10(-4))) while remaining unchanged in the placebo group (2.9 (2.6-3.2) v 2.9 (2.5-3. 3)), the mean reduction in pain score being significantly different between the two groups (p<10(-4)). There was no indication of increased postoperative ocular inflammation, intraocular pressure change, or endothelial cell loss. CONCLUSIONS: These results suggest that it may not be necessary to systematically add intracameral anaesthesia with topical anaesthesia for cataract surgery. An intraoperative intracameral injection, performed only in patients who happen to suffer during surgery, is safe and effective.
RCT Entities:
AIM: To assess the efficacy and safety of an intraoperative intracameral injection of mepivacaine, administered when patients experienced pain during the course of cataract surgery under topical anaesthesia. METHODS: This is a prospective placebo controlled double masked randomised clinical trial. 50 eyes were included; 25 receiving the active compound and 25 receiving placebo. Mepivacaine (2%, 0.4 ml) or placebo was administered intraoperatively under the iris of the patients who experienced pain during the course of phacoemulsification in spite of previous topical anaesthesia. Efficacy was evaluated by the patients themselves using a five point subjective pain rating scale, the Keele verbal pain chart. Safety was measured by assessing intraocular inflammation (clinical evaluation and laser flare meter), intraocular pressure, and endothelial cell count. RESULTS: The pain rating score significantly diminished after intracameral injection in the mepivacaine group (mean 3.0 (95% CI 2.6-3.4) v 0.8 (0.3-1.3), p<10(-4))) while remaining unchanged in the placebo group (2.9 (2.6-3.2) v 2.9 (2.5-3. 3)), the mean reduction in pain score being significantly different between the two groups (p<10(-4)). There was no indication of increased postoperative ocular inflammation, intraocular pressure change, or endothelial cell loss. CONCLUSIONS: These results suggest that it may not be necessary to systematically add intracameral anaesthesia with topical anaesthesia for cataract surgery. An intraoperative intracameral injection, performed only in patients who happen to suffer during surgery, is safe and effective.
Authors: A S Crandall; N A Zabriskie; B C Patel; T A Burns; N Mamalis; L A Malmquist-Carter; R Yee Journal: Ophthalmology Date: 1999-01 Impact factor: 12.079