Dataset Information

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

ACCESS DATA

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]

PMID: 33610175

Similar Datasets

Project description:ImportancePerforming elective upper and lower endoscopic procedures on the same day is a patient-centered and less costly approach than a 2-stage approach performed on different days, when clinically appropriate. Whether this practice pattern varies based on practice setting has not been studied.ObjectivesTo estimate the rate of different-day upper and lower endoscopic procedures in 3 types of outpatient settings and investigate the factors associated with the performance of these procedures on different days.Design, setting, and participantsA retrospective analysis was conducted of Medicare claims between January 1, 2011, and June 30, 2018, for Medicare beneficiaries who underwent a pair of upper and lower endoscopic procedures performed within 90 days of each other at hospital outpatient departments (HOPDs), freestanding ambulatory surgery centers (ASCs), and physician offices.Main outcomes and measuresUndergoing an upper and a lower endoscopic procedure on different days, adjusted for patient characteristics (age, sex, race/ethnicity, residence location and region, comorbidity, and procedure indication) and physician characteristics (sex, years in practice, procedure volume, and primary specialty). Adjusted odds ratios (aORs) and 95% CIs were calculated.ResultsA total of 4 028 587 procedure pairs were identified, of which 52.5% were performed in HOPDs, 43.3% in ASCs, and 4.2% in physician offices. The rate of different-day procedures was 13.6% in HOPDs, 22.2% in ASCs, and 47.7% in physician offices. For the 7564 physicians who practiced at both HOPDs and ASCs, their different-day procedure rate changed from 14.1% at HOPDs to 19.4% at ASCs. For the 993 physicians who practiced at both HOPDs and physician offices, their different-day procedure rate changed from 15.8% at HOPDs to 37.4% at physician offices. Patients were more likely to undergo different-day procedures at physician offices and ASCs compared with HOPDs, even after adjusting for patient and physician characteristics (physician office vs HOPD: aOR, 2.02; 95% CI, 1.85-2.20; ASC vs HOPD: aOR, 1.27; 95% CI, 1.23-1.32). Older age (85-94 years vs 65-74 years: aOR, 1.10; 95% CI, 1.08-1.11; 95 years or older vs 65-74 years: aOR, 1.14; 95% CI, 1.03-1.26), black and Hispanic race/ethnicity (black: aOR, 1.15; 95% CI, 1.12-1.17; Hispanic: aOR, 1.12; 95% CI, 1.10-1.14), and residing in the Northeast region (adjusted OR, 1.32; 95% CI, 1.28-1.36) were risk factors for undergoing different-day procedures. Micropolitan location (aOR, 0.94; 95% CI, 0.92-0.96) and rural location (aOR, 0.91; 95% CI, 0.89-0.93), more comorbidities (≥5: aOR, 0.75; 95% CI, 0.74-0.76), physician's fewer years in practice (aOR, 0.84; 95% CI, 0.81-0.87), physician's higher procedure volume (aOR, 0.65; 95% CI, 0.62-0.68), and physician's specialty of general surgery (aOR, 0.86; 95% CI, 0.80-0.91) were protective factors.Conclusions and relevancePhysician offices and ASCs had much higher different-day procedure rates compared with HOPDs. This disparity may represent an opportunity for quality improvement and financial savings for common endoscopic procedures.

Project description:BackgroundMany believe that variation in vascular practice may affect limb salvage rates in patients with severe peripheral arterial disease. However, the extent of variation in procedural vascular care obtained by patients with critical limb ischemia (CLI) remains unknown.Methods and resultsBy using Medicare 2003 to 2006 data, we identified all patients with CLI who underwent major lower extremity amputation in the 306 hospital referral regions described in the Dartmouth Atlas of Healthcare. For each patient, we studied the use of lower extremity vascular procedures (open surgery or endovascular intervention) in the year before amputation. Our main outcome measure was the intensity of vascular care, defined as the proportion of patients in the hospital referral region undergoing a vascular procedure in the year before amputation. Overall, 20,464 patients with CLI underwent major lower extremity amputations during the study period, and collectively underwent 25,800 vascular procedures in the year before undergoing amputation. However, these procedures were not distributed evenly: 54% of patients had no vascular procedures performed in the year before amputation, 14% underwent 1 vascular procedure, and 32% underwent >1 vascular procedure. In the regions in the lowest quintile of vascular intensity, vascular procedures were performed in 32% of patients. Conversely, in the regions in the highest quintile of vascular intensity, revascularization was performed in 58% of patients in the year before amputation (P<0.0001). In analyses accounting for differences in age, sex, race, and comorbidities, patients in high-intensity regions were 2.4 times as likely to undergo revascularization in the year before amputation than patients in low-intensity regions (adjusted odds ratio, 2.4; 95% CI, 2.1-2.6; P<0.001).ConclusionsSignificant variation exists in the intensity of vascular care provided to patients in the year before major amputation. In some regions, patients receive intensive care, whereas in other regions, far less vascular care is provided. Future work is needed to determine the association between intensity of vascular care and limb salvage.

Project description:ObjectiveTo examine the associations between neuraxial anaesthesia or general anaesthesia and clinical outcomes, length of hospital stay, and readmission in adults undergoing lower limb revascularisation surgery.DesignComparative effectiveness study using linked, validated, population based databases.SettingOntario, Canada, 1 April 2002 to 31 March 2015.Participants20 988 patients Ontario residents aged 18 years or older who underwent their first lower limb revascularisation surgery in hospitals performing 50 or more of these surgeries annually.Main outcome measuresPrimary outcome was 30 day all cause mortality. Secondary outcomes were in-hospital cardiopulmonary and renal complications, length of hospital stay, and 30 day readmissions. Multivariable, mixed effects regression models, adjusting for patient, procedural, and hospital characteristics, were used to estimate associations between anaesthetic technique and outcomes. Robustness of analyses were evaluated by conducting instrumental variable, propensity score matched, and survival sensitivity analyses.ResultsOf 20 988 patients who underwent lower limb revascularisation surgery, 6453 (30.7%) received neuraxial anaesthesia and 14 535 (69.3%) received general anaesthesia. The percentage of neuraxial anaesthesia use ranged from 0.6% to 90.6% across included hospitals. Furthermore, use of neuraxial anaesthesia declined by 17% over the study period. Death within 30 days occurred in 204 (3.2%) patients who received neuraxial anaesthesia and 646 (4.4%) patients who received general anaesthesia. After multivariable, multilevel adjustment, use of neuraxial anaesthesia compared with use of general anaesthesia was associated with decreased 30 day mortality (absolute risk reduction 0.72%, 95% confidence interval 0.65% to 0.79%; odds ratio 0.68, 95% confidence interval 0.57 to 0.83; number needed to treat to prevent one death=139). A similar direction and magnitude of association was found in instrumental variable, propensity score matched, and survival analyses. Use of neuraxial anaesthesia compared with use of general anaesthesia was also associated with decreased in-hospital cardiopulmonary and renal complications (odds ratio 0.73, 0.63 to 0.85) and a reduced length of hospital stay (-0.5 days, -0.3 to-0.6 days).ConclusionsUse of neuraxial anaesthesia compared with general anaesthesia for lower limb revascularisation surgery was associated with decreased 30 day mortality and hospital length of stay. These findings might have been related to reduced cardiopulmonary and renal complications after neuraxial anaesthesia and support the increased use of neuraxial anaesthesia in patients undergoing these surgeries until the results of a large, confirmatory randomised trial become available.

Project description:One undisputed benefit of digital support is the possibility of contact reduction, which has become particularly important in the context of the COVID-19 pandemic. However, to the best of our knowledge, there is currently no study assessing the Europe-wide use of digital online pre-operative patient information or evaluation in the health sector. The aim of this study was to give an overview of the current status in Europe. A web-based questionnaire covering the informed consent process was sent to members of the European Society of Anaesthesia and Intensive Care Medicine (ESAIC) in 47 European countries (42,433 recipients/930 responses). Six questions related specifically to the practice in paediatrics. A total of 70.2% of the respondents indicated that it was not possible to obtain informed consent via the Internet in a routine setting, and 67.3% expressed that they did not know whether it is in line with the legal regulations. In paediatric anaesthesia, the informed consent of only one parent was reported to be sufficient by 77.6% of the respondents for simple interventions and by 63.8% for complex interventions. Just over 50% of the respondents judged that proof of identity of the parents was necessary, but only 29.9% stated that they ask for it in clinical routine. In the current situation, 77.9% would favour informed consent in person, whereas 60.2% could imagine using online or telephone interviews as an alternative to a face-to-face meeting if regulations were changed. Only 18.7% participants reported a change in the regulations due to the current pandemic situation. Whether informed consent is obtained either online or on the telephone in the paediatric population varies widely across Europe and is not currently implemented as standard practice. For high-risk patients, such as the specific cohort of children with congenital heart defects, wider use of telemedicine might provide a benefit in the future in terms of reduced contact and reduced exposure to health risks through additional hospital stays.

Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets