P C Jacobi1, T S Dietlein, F K Jacobi. 1. Department of Ophthalmology, University of Cologne, Joseph-Stelzmannstrasse 9, 50931 Cologne, Germany. Phillip.Jacobi@uni-koeln.de.
Abstract
OBJECTIVES: To evaluate and compare levels of patient discomfort and perioperative complications during phacoemulsification and implantation of a foldable intraocular lens under topical lidocaine hydrochloride and retrobulbar anesthesia in patients with cataract who also had exfoliation syndrome, uveitis, posterior synechia, phacodonesis, or previous intraocular surgery. DESIGN: A prospective, randomized, controlled trial was carried out at 2 institutions. PARTICIPANTS: A total of 476 eyes of 476 patients with various well-established risk factors fulfilled the inclusion criteria. In 238 eyes, phacoemulsification was performed under retrobulbar anesthesia, while the other 238 eyes receivedtopical anesthesia. INTERVENTIONS: All patients underwent temporal clear corneal phacoemulsification and implantation of a foldable intraocular lens. Patients under retrobulbar anesthesia received a single injection (3. 5-5.5 mL) of a combination of 0.75% bupivacaine hydrochloride, 2% lidocaine, and hyaluronidase into the retrobulbar space. Patients in the topical anesthesia group received a minimum of 5 doses (approximately 40 microL per dose) of 2% topical lidocaine. No intracameral injection of any anesthetic was given. MAIN OUTCOME MEASURES: The number of complications and adverse events. The intraoperative conditions were judged by the surgeon (P.C.J. or F.K. J.), and a 10-point visual analog scale was used immediately after surgery to assess each patient's overall severity of intraoperative pain. RESULTS: The overall intraoperative complication rate was 1.9% for capsular tear, 3.8% for zonular tear, 1.5% for vitreous loss, and 1.0% for iris prolapse. Apart from the incidence of vitreous loss, which was significantly (P =.041) lower in the topical anesthesia group, no statistically significant differences in intraoperative and early postoperative complications were found between the groups. A supplemental posterior sub-Tenon space injection was required in 1.3% of the topical anesthesia group and in 0.8% of the retrobulbar anesthesia group. Chemosis (2.5%), subconjunctival hemorrhage (1.7%), and periorbital hematoma (0.8%) were seen only in the retrobulbar anesthesia group. The mean + SE pain scores estimated by the patients were 0.84 + 1.30 in the topical anesthesia group and 0.73 + 1.50 in the retrobulbar anesthesia group (P =.41). Patient preference for topical anesthesia (91%) appeared to be significantly (P =.01) higher than for retrobulbar anesthesia (62%). The surgeons found anesthesia-related intraoperative difficulty to be slightly lower in the retrobulbar anesthesia group (8%) than in the topical anesthesia group (14%). CONCLUSIONS: Surgery-related complications and patient discomfort were similar for the 2 methods of anesthesia. Topical anesthesia is justified as a means of improving safety without causing discomfort to the patient even in complicated cases of cataract surgery. Arch Ophthalmol. 2000;118:1037-1043
RCT Entities:
OBJECTIVES: To evaluate and compare levels of patient discomfort and perioperative complications during phacoemulsification and implantation of a foldable intraocular lens under topical lidocaine hydrochloride and retrobulbar anesthesia in patients with cataract who also had exfoliation syndrome, uveitis, posterior synechia, phacodonesis, or previous intraocular surgery. DESIGN: A prospective, randomized, controlled trial was carried out at 2 institutions. PARTICIPANTS: A total of 476 eyes of 476 patients with various well-established risk factors fulfilled the inclusion criteria. In 238 eyes, phacoemulsification was performed under retrobulbar anesthesia, while the other 238 eyes received topical anesthesia. INTERVENTIONS: All patients underwent temporal clear corneal phacoemulsification and implantation of a foldable intraocular lens. Patients under retrobulbar anesthesia received a single injection (3. 5-5.5 mL) of a combination of 0.75% bupivacaine hydrochloride, 2% lidocaine, and hyaluronidase into the retrobulbar space. Patients in the topical anesthesia group received a minimum of 5 doses (approximately 40 microL per dose) of 2% topical lidocaine. No intracameral injection of any anesthetic was given. MAIN OUTCOME MEASURES: The number of complications and adverse events. The intraoperative conditions were judged by the surgeon (P.C.J. or F.K. J.), and a 10-point visual analog scale was used immediately after surgery to assess each patient's overall severity of intraoperative pain. RESULTS: The overall intraoperative complication rate was 1.9% for capsular tear, 3.8% for zonular tear, 1.5% for vitreous loss, and 1.0% for iris prolapse. Apart from the incidence of vitreous loss, which was significantly (P =.041) lower in the topical anesthesia group, no statistically significant differences in intraoperative and early postoperative complications were found between the groups. A supplemental posterior sub-Tenon space injection was required in 1.3% of the topical anesthesia group and in 0.8% of the retrobulbar anesthesia group. Chemosis (2.5%), subconjunctival hemorrhage (1.7%), and periorbital hematoma (0.8%) were seen only in the retrobulbar anesthesia group. The mean + SE pain scores estimated by the patients were 0.84 + 1.30 in the topical anesthesia group and 0.73 + 1.50 in the retrobulbar anesthesia group (P =.41). Patient preference for topical anesthesia (91%) appeared to be significantly (P =.01) higher than for retrobulbar anesthesia (62%). The surgeons found anesthesia-related intraoperative difficulty to be slightly lower in the retrobulbar anesthesia group (8%) than in the topical anesthesia group (14%). CONCLUSIONS: Surgery-related complications and patient discomfort were similar for the 2 methods of anesthesia. Topical anesthesia is justified as a means of improving safety without causing discomfort to the patient even in complicated cases of cataract surgery. Arch Ophthalmol. 2000;118:1037-1043