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Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients.


ABSTRACT:

Background

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).

Methods

After 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.

Results

Times 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).

Conclusions

The 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 registration

Registration of clinical trial: clinicaltrials.gov ( NCT02481505 ).

SUBMITTER: Ghisi D 

PROVIDER: S-EPMC7896357 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients.

Ghisi Daniela D   Boschetto Giorgia G   Spinelli Alessandra Maria AM   Giannone Sandra S   Frugiuele Jacopo J   Ciccarello Marcello M   Bonarelli Stefano S  

BMC anesthesiology 20210220 1


<h4>Background</h4>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).<h4>Methods</h4>After informed consent, we enrolled 45 male and female patients, aged 18-65 years, ASA score I-II, BMI 18-32 kg/m<sup>2</sup>, undergoing elective lower limb procedures lasting ≤40 min and with a requested dermatome  ...[more]

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