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Randomized Controlled Trial
Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients.
- Daniela Ghisi, Giorgia Boschetto, Alessandra Maria Spinelli, Sandra Giannone, Jacopo Frugiuele, Marcello Ciccarello, and Stefano Bonarelli.
- Anesthesia, Intensive Care and Pain Therapy, Istituto Ortopedico Rizzoli, via G.C. Pupilli 1, 40136, Bologna, Italy. ghisidan@gmail.com.
- BMC Anesthesiol. 2021 Feb 20; 21 (1): 58.
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 ).
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