Abstract
BackgroundThis prospective, randomised, observer-blinded study has been conducted in patients undergoing procedures of the lower extremities to evaluate the time to complete block resolution of 2-chloroprocaine 1% at three intrathecal doses (30, 40 and 50 mg).MethodsAfter informed consent, we enrolled 45 male and female patients, aged 18–65 years, ASA score I-II, BMI 18–32 kg/m2, undergoing elective lower limb procedures lasting ≤40 min and with a requested dermatomeric level of sensory block ≥ T12.The patients were randomised in a 1:1:1 ratio to receive Chloroprocaine HCl 1% at one of the three different intrathecal doses (Group 30 = 30 mg, Group 40 = 40 mg or Group 50 = 50 mg). The progression and regression of both sensory and motor blocks were evaluated blindly. Urine and venous blood samples were collected for pharmacokinetic analysis.ResultsTimes to regression of spinal blocks were 1.76 ± 0.35 h, 2.13 ± 0.46 h and 2.23 ± 0.38 h, in Group 30, 40 and 50 respectively: the 30 mg dose showed a significantly faster resolution of spinal block than the 40 mg (p = 0.034) and the 50 mg (p = 0.006). Time to readiness for surgery was significantly reduced with the dose of 50 mg when compared to dose of 30 mg (p = 0.0259).ConclusionsThe doses of 50 mg and 40 mg yielded a longer resolution of spinal block than the dose of 30 mg. Nevertheless, the dose of 30 mg resulted in a higher secondary failure rate.Trial registrationRegistration of clinical trial: clinicaltrials.gov (NCT02481505).
Highlights
Clinical studies in volunteers investigated chloroprocaine use for spinal anaesthesia at doses ranging between 30 and 60 mg [1, 2]
Goldblum and Atchabahian recommended the dose of 30 mg for surgery of the lower extremities up to 40–60 min duration [7]. We conducted this prospective, randomized, observer-blind study in adult patients to reevaluate the efficacy of chloroprocaine HCl 1% conservative free solution at the doses previously investigated (30, 40 and 50 mg) for spinal anaesthesia in shorter procedures of the lower limbs
The present study served as a phase II clinical study for the Food and Drug Administration (FDA) approval of the intrathecal use of 2-chloroprocaine 1%
Summary
Clinical studies in volunteers investigated chloroprocaine use for spinal anaesthesia at doses ranging between 30 and 60 mg [1, 2]. Goldblum and Atchabahian recommended the dose of 30 mg for surgery of the lower extremities up to 40–60 min duration [7] We conducted this prospective, randomized, observer-blind study in adult patients to reevaluate the efficacy of chloroprocaine HCl 1% conservative free solution at the doses previously investigated (30, 40 and 50 mg) for spinal anaesthesia in shorter procedures of the lower limbs. The study inlcudes the analysis of the pharmacokinetic profile of the drug after intrathecal administration to confirm the low systemic exposure to chloroprocaine following spinal injection This prospective, randomised, observer-blinded study has been conducted in patients undergoing procedures of the lower extremities to evaluate the time to complete block resolution of 2-chloroprocaine 1% at three intrathecal doses (30, 40 and 50 mg)
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