Spinal Anesthesia in Caesarean Section: Comparison Between Levobupivacaine and Hyperbaric Bupivacaine
Description:
This is a prospective, monocentric, not for-profit, observational study, with historical
control group, whose primary objective is the monitoring of changes in the hemodynamic
condition, intended as continuous pressure measurements by means of a non-invasive system
(EV1000® platform + Clearsight® system – Edwards Lifesciences), of a group of 125 pregnant
women who have to undergo spinal anesthesia with Levobupivacaine for elective cesarean
section at the "G. Rodolico" Presidium of Azienda Ospedaliero Universitaria
"Policlinco-Vittorio Emanuele" of Catania, and to compare them with those detected, with the
same non-invasive system, in an historical cohort of 125 patients who underwent spinal
anesthesia with Bupivacaine for an elective caesarean section in the period between April
2017 and April 2018.
The study will have an expected duration of one year from the time of its approval.
In the levobupivacaine group, during the preoperative anesthesiological examination, carried
out approximately two weeks before the scheduled date of the surgical intervention, informed
consent will be acquired and the eligible patients will be enrolled. On this occasion, an ASA
class will be assigned and the following data will be collected:
– personal and general data:
– date of birth and age
– current weight
– weight before pregnancy
– height
– information concerning:
– any previous or concomitant diseases affecting the nervous, respiratory,
cardiovascular system
– any previous or concomitant disease interesting: gastrointestinal system,
hemolymphatic system, thyroid, pancreas, kidneys, liver, adrenal glands
– any immunodeficiencies
– any coagulopathies
– spinal deformities
– previous surgeries
– previous allergic events following the administration of drugs
– seasonal allergies
– previous pregnancies and their characteristics
– possible hypertension during the last quarter
– conditions that represent contraindications for spinal anesthesia. Upon arrival in
the operating room, the Clearsight® non-invasive hemodynamic monitoring system will
be placed at the fingers of the parturient and the usual intraoperative monitoring
(ECG, non-invasive blood pressure, oxygen saturation) will be applied. The
continuous recording of the following hemodynamic parameters, which will last for
the whole duration of the intervention, will then begin through the EV1000®
platform (Edwards Lifesciences): Cardiac Output (CO); Cardiac Index (CI); Stroke
Volume (SV); Stroke Volume Index (SVI); Stroke Volume Variation (SVV); Pulse Rate
Variation (PRV); Systemic Vascular Resistance (SVR); Systemic Vascular Resistance
Index (SVRI); Central Venous Oxygen Saturation (ScvO2); Pulse rate (PR); Systolic
Pressure (SYS); Diastolic Pressure (DIA); Mean Arterial Pressure (MAP); Central
Venous Pressure (CVP).These measurements will be made every twenty seconds.
Once the monitoring system has been applied, the patients will be placed in position and
spinal anesthesia will be performed with Levobupivacaine 12 mg 0.5% and Fentanyl 25γ. Once
the anesthetic is injected, patients will be subjected to dislocation of the uterus and
placed in left lateral tilt. Once the sensory and motor block has been obtained, the surgery
will begin. In the event of adverse reactions to the drug, therapeutic measures that are part
of the usual clinical practice will be used.
Any episodes of hypotension during the operation will be treated by administration of 5 mg
etilefrine in bolus and/or IV fluids; any episodes of bradycardia will be treated by
administration of IV atropine 0.01 mg/kg.
Sensory block will be evaluated by objective examination: the investigators will evaluate the
tactile discrimination ability of a blunt tip in contact with the patient’s back, thus
determining the level of anesthesia reached and the time in which it occurs. The measurements
of this parameter will be carried out every fifteen minutes, during the first half hour, and
then at thirty and sixty minutes until the restitutio of the physiological condition of the
patient.
The motor block will be evaluated by Bromage score, ie by observing the residual motor
capacity of the patient’s lower limbs. The measurements of this parameter will be carried out
every fifteen minutes, during the first half hour, and then at thirty and sixty minutes until
the restitutio of the physiological condition of the patient.
For calculating the Aldrete’s score, the following parameters will be assessed: respiration
and consciousness through objective examination, systolic blood pressure using the classic
intraoperative monitoring system and pulse oximetry oxygenation. The measurements of this
score will be carried out every fifteen minutes during the first half hour, and then at
thirty and sixty minutes until the restitutio of the physiological condition of the patient.
Patient data from the historical cohort will be collected by reviewing the clinical
documentation related to the individual case.
Once collected, the data will be subjected to statistical and comparative processing in order
to highlight statistically relevant differences concerning the effects mediated by the two
anesthetics on the pregnant patient who undergoes elective cesarean section.
The data obtained will be analyzed using the SPSS software (Statistical Package for Social
Sciences), version 21.0 for Windows (SPSS Inc., Chicago, Illinois, USA). Differences with p≤
0.05 will be considered significant.
The descriptive analysis will be performed using frequencies, percentages and frequency
tables for qualitative variables. For the normally distributed quantitative variables the
mean and standard deviation will be used, while for those not normally distributed the median
and the interquartile range (IQR) will be used. For the comparison between the two groups
will be used the Chi-square test with Yates correction or Fisher exact test for qualitative
variables and the Mann-Whitney U test for quantitative variables.
Multivariate analysis will be performed using logistic regression models and the ORs (odds
ratios) will be reported together with the corresponding 95% confidence intervals.
Condition:
Hypotension Drug-Induced
Treatment:
Levobupivacaine
Start Date:
June 1, 2018
Sponsor:
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
For More Information:
https://clinicaltrials.gov/show/NCT03743870