Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions
- Conditions
- Hemodynamic InstabilityEpiduralFetal Cardiac DisorderPregnancy
- Interventions
- Registration Number
- NCT05877131
- Lead Sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Brief Summary
INTRODUCTION:
Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being.
METHODOLOGY/DESIGN:
It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects.
DISCUSSION:
Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.
- Detailed Description
Any patient presenting in the delivery room or gynecology-obstetrics office of the hospital with prodromes, midwives or gynecologists will inform the principal investigator (PI). The IP will contact the patient to inform them of what the study consists of and if they wish to participate in it. In case of acceptance, the explanatory documentation and a questionnaire will be delivered to determine if it meets the inclusion criteria. If the pregnant patient at term meets the inclusion criteria, she is recruited to enter the study, it will also be used to resolve any doubts that the patient may have. Once the patient has signed the informed consent, the collaborating researcher (CI) of the recruiting center will be notified to contact the Althaia Innovation and Research Unit to find out the patient's assignment group. The collaborating researcher will be in charge of notifying the patient of the group to which she has been assigned (Intervention Group A or B).
Initially, the basal hemodynamic constants will be recorded: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), systemic vascular resistance (SVR), cardiac output (CO), index Pulse Pressure Variation (PPV), Stroke Volume Variation (SVV), Heart Rate (HR), Stroke Volume (SV), Partial Pressure Oxygen Saturation (SpO2) via Clearsight device ®; pain score (VAS); degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The FHR will also be recorded, as well as the different pathological patterns of the RCTG that appear, the Philips Avalon FM 30 monitor will be used for this.
The steps to follow for the administration of local anesthetic through the epidural catheter will be the following:
The mother's data (before and after AE) will be collected, including hemodynamic data: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), vascular resistance heart rate (SVR), cardiac output (CO), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (VSV), heart rate (HR), stroke volume (SV), blood saturation partial pressure of oxygen (SpO2); pain score (VAS), degree of analgesia achieved, satisfaction obtained, time onset of analgesia, level of sensory block using the pin-prick test and the hot-cold test; degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The fetal data (before and after the AE) of the FHR (values above or below the normal limits) will also be included, as well as the different pathological patterns of the RCTG that appear, due to hypotension or alterations. associated hemodynamics.
All pregnant women who will participate in this study will carry an intravenous cannula and will receive a fluid load of 500 cc. The position of the patients will be in a sitting position and the epidural puncture will be performed at the level of the L2-3 or L3-4 intervertebral space using a Tuohy 18 epidural needle. The loss of resistance technique with air or saline will be used according to the standards of our service.
A volume of 2 ml of 2% lidocaine will be administered via the epidural via the epidural catheter, after 3 minutes (it will be evaluated if undesirable effects appear: such as motor block due to accidental dural puncture, hypotension, nausea, vomiting), it will be administered to pregnant women the final volume (10 cc) of the local anesthetic randomly assigned via epidural.
After the administration of the initial bolus (Group A - Group B), the different constants or parameters to be evaluated will be recorded.
The measurement of the different hemodynamic variables will be recorded through a non-invasive device, the Clearsight®. The device will automatically determine the constants, which will be recorded at 5, 10, 15, 30, 45 and 60 minutes.
In the event of recording an episode of hypotension after the first 60 minutes, a record of all the hemodynamic variables evaluated will be made every 5 minutes for the following 60 minutes.
It will be determined which of the local anesthetics at low concentrations administered via the epidural is related to alteration of the hemodynamic parameters. To measure the different parameters, a non-invasive device (Clearsight) will be used, which will determine the existing hemodynamic alterations before, after, and during the first hour after the administration of the initial dose through the lumbar epidural catheter, as well as in the event of an episode. of hypotension or changes in FHR and/or RCTG after the first hour of catheter placement.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
-
- Woman > 18 years
- Request epidural anesthesia (EA)
- Expansion period
- Low obstetric risk
- ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.)
- Cervix dilation ≥ 3
- single fetus
- Gestational age > 36 weeks
- Normal Fetal Heart Rate (110 -160 beats / minute)
- Normal Cardiotocographic record or absence of fetal heart rate patterns suggestive of risk of loss of fetal well-being or non-reassuring cardiotocographic record.
- VAS ≤ 2
- Breech presentation
- Maternal fever > 38 years
- Pre-eclampsia and severe eclampsia
- Prenatal bleeding
- ASA II (more than one comorbidity)
- Chronic pain
- Substance abuse
- Contraindications for epidural analgesia (EA)
- Allergy to local anesthetics
- BMI >40 kg/m²
- Presence of RCTG not reassuring
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaina Levobupivacaine Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour Ropivacaina Ropivacaine Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour
- Primary Outcome Measures
Name Time Method Systemic vascular resistance ( units of measure :dyn*s/cm5) 60 minutes after epidural Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5) 45 minutes after epidural Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
- Secondary Outcome Measures
Name Time Method Stroke Volume (units of measure :ml) 60 minutes after epidural Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Fetal heart rate (units of measure: beats per minute) 60 minutes after epidural The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Decelerations (units of measure: beats per minute) 60 minutes after epidural These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Pulse Pressure (units of measure :mmHg) 60 minutes after epidural Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Cardiac Output (units of measure :L/min) 60 minutes after epidural The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volumeArterial Oxigen Saturation ( units of measure :% Percent) 60 minutes after epidural Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Mean Arterial Pressure (units of measure :mmHg) 60 minutes after epidural Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVCCardiac Index ( units of measure :L/min/m2) 60 minutes after epidural A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate \* Stroke Volume) / Body Surface AreaDiastolic Blood Pressure (units of measure :mmHg) 60 minutes after epidural Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Pulse Pressure Variation ( units of measure :% Percent) 60 minutes after epidural Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as \[(PPmax - PPmin)/(PPmax
+ PPmin)/2\] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectivelyVariability (units of measure: beats per minute) 60 minutes after epidural This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Systolic Blood Pressure (units of measure :mmHg) 60 minutes after epidural Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
(Maternal) Heart Rate (units of measure: beats per minute) 60 minutes after epidural The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.Systolic Variation Volume ( units of measure :% Percent) 60 minutes after epidural Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Accelerations (units of measure: beats per minute) 60 minutes after epidural These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Trial Locations
- Locations (1)
Althaia Xarxa Assitensial i Universitaria Manresa
🇪🇸Manresa, Barcelona, Spain