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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A double-blind comparison of ropivacaine 0.5%, 0.75%, 1.0% and bupivacaine 0.5%, injected epidurally, in patients undergoing abdominal hysterectomy.
- B T Finucane, A N Sandler, J McKenna, D Reid, A L Milner, M Friedlander, D Muzyka, S O'Callaghan-Enright, and V Chan.
- Department of Anaesthesia, University of Alberta, Toronto, Canada.
- Can J Anaesth. 1996 May 1;43(5 Pt 1):442-9.
PurposeRopivacaine is a new long-acting, injectable local anaesthetic currently undergoing clinical investigation world wide. It is structurally very similar to bupivacaine, but with less potential for central nervous system or cardiac toxicity. The purpose of this double-blind study was: to investigate the dose-response relationship of increasing doses of ropivacaine on the quality of anaesthesia and the duration of both motor and sensory blockade, and to compare these results with an established local anaesthetic, bupivacaine.MethodsOne hundred and twenty five patients were randomly assigned to one of four treatment groups and 116 completed the study. Epidural anaesthesia was established using 25 ml test solution, injected over three minutes following a satisfactory test dose. Sensory onset, spread and duration, using the pin prick method, and motor scores using a modified Bromage scoring system were compared.ResultsA dose/response relationship was observed with increasing doses of ropivacaine for all variables tested except analgesia and muscle relaxation (P < 0.01). There were differences in: (i) motor onset (Levels 1 and 2), when ropivacaine 1.0% was compared with ropivacaine 0.75% and 0.5% (P < 0.05); (ii) in sensory duration at all levels except T6 when ropivacaine was compared with ropivacaine 0.5% (P < 0.05); (iii) differences in sensory duration at T12 and S1 when ropivacaine 1.0% was compared with bupivacaine 0.5% (P < 0.05); (iv) differences in motor duration at all levels when ropivacaine 1.0% was compared with ropivacaine 0.5% (P < 0.05). No serious adverse events were reported in this study.ConclusionIncreasing doses of ropivacaine were associated with an increased clinical effect. The most consistent differences occurred when ropivacaine 1.0% was compared with 0.5% and the least consistent between ropivacaine 0.5%, 0.75% and bupivacaine 0.5%. The main difference between ropivacaine 1.0% and bupivacaine was in sensory duration. No serious adverse events were reported.
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