ABSTRACT
OBJECTIVE: The relative efficacy of two bupivacaine hydrochloride injection products was investigated in patients who were undergoing intra-ocular eye surgery. DESIGN: Patients took part in this double-blind, randomised, parallel-group study and received either Macaine (Keatings) or Regibloc (Intramed), according to the randomisation schedule. SETTING: The study was carried out in the ophthalmology operating theatres of National and Pelonomi Hospitals, Bloemfontein, South Africa. PATIENTS: Thirty male and 74 female patients who needed extra-capsular lens extraction plus intra-ocular lens implantation, extra-capsular lens extraction, or trabeculectomy were selected for the study. OUTCOME MEASURES: Akinesia was evaluated after 10, 15 and 20 minutes. In the event of incomplete akinesia after 20 minutes, an additional injection was administered, and after 5 minutes another evaluation of akinesia was done. Anaesthesia was evaluated at the beginning of surgery. RESULTS: The proportions of patients who received no additional anaesthesia were 57.7% for Macaine and 70.8% for Regibloc (difference 13.1%, 95% confidence interval (CI) -5.5 - 31.7%). The proportions of patients with adequate akinesia (possibly after additional anaesthesia) were 90.4% for Macaine and 89.6% for Regibloc (difference -0.8%, 95% CI-12.6 - 11.0%). The proportions of patients experiencing no pain or discomfort at the beginning of surgery were 88.2% for Macaine and 87.5% for Reglibloc (difference -0.7%, 95% CI-13.6 - 12.1%). CONCLUSION: The study results indicate that Regibloc is at least as effective as, or superior to, Macaine in achieving adequate akinesia.
