Clinical trial NCT05877131: Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions
Official title: Randomized Clinical Trial to Evaluate the Efficacy of Levobupivacaine 0.125% vs Ropivacaine 0.2%, in Hemodynamic Alterations in Pregnant Women in Labor and Their Fetal Repercussions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodynamic Instability
Epidural
Pregnancy
Fetal Cardiac Disorder
Keywords: Hemodynamic instability
Epidural
Pregnancy
Fetal Cardiac disorder
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* - 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 10 minutes before epidural
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 5 minutes after epidural
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 10 minutes after epidural
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 15 minutes after epidural
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 30 minutes after epidural
measure: Systemic vascular resistance ( units of measure:dyn*s/cm5)
timeFrame: 45 minutes after epidural
measure: Systemic vascular resistance ( units of measure :dyn*s/cm5)
timeFrame: 60 minutes after epidural
Secondary outcomes:
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 10 minutes before epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 5 minutes after epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 10 minutes after epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 15 minutes after epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 30 minutes after epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 45 minutes after epidural
measure: Systolic Blood Pressure (units of measure :mmHg)
timeFrame: 60 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 10 minutes before epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 5 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 10 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 15 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 30 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 45 minutes after epidural
measure: Diastolic Blood Pressure (units of measure :mmHg)
timeFrame: 60 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 10 minutes before epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 5 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 10 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 15 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 30 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 45 minutes after epidural
measure: Mean Arterial Pressure (units of measure :mmHg)
timeFrame: 60 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 10 minutes before epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 5 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 10 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 15 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 30 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 45 minutes after epidural
measure: Pulse Pressure (units of measure :mmHg)
timeFrame: 60 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 10 minutes before epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 5 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 10 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 15 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 30 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 45 minutes after epidural
measure: Cardiac Output (units of measure :L/min)
timeFrame: 60 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 10 minutes before epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 5 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 10 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 15 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 30 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 45 minutes after epidural
measure: Cardiac Index ( units of measure :L/min/m2)
timeFrame: 60 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 10 minutes before epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 5 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 10 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 15 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 30 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 45 minutes after epidural
measure: Pulse Pressure Variation ( units of measure :% Percent)
timeFrame: 60 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 10 minutes before epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 5 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 10 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 15 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 30 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 45 minutes after epidural
measure: (Maternal) Heart Rate (units of measure: beats per minute)
timeFrame: 60 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 10 minutes before epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 5 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 10 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 15 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 30 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 45 minutes after epidural
measure: Stroke Volume (units of measure :ml)
timeFrame: 60 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 10 minutes before epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 5 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 10 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 15 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 30 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 45 minutes after epidural
measure: Systolic Variation Volume ( units of measure :% Percent)
timeFrame: 60 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 10 minutes before epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 5 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 10 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 15 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 30 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 45 minutes after epidural
measure: Arterial Oxigen Saturation ( units of measure :% Percent)
timeFrame: 60 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 10 minutes before epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 5 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 10 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 15 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 30 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 45 minutes after epidural
measure: Fetal heart rate (units of measure: beats per minute)
timeFrame: 60 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 10 minutes before epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 5 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 10 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 15 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 30 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 45 minutes after epidural
measure: Variability (units of measure: beats per minute)
timeFrame: 60 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 10 minutes before epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 5 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 10 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 15 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 30 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 45 minutes after epidural
measure: Accelerations (units of measure: beats per minute)
timeFrame: 60 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 10 minutes before epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 5 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 10 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 15 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 30 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 45 minutes after epidural
measure: Decelerations (units of measure: beats per minute)
timeFrame: 60 minutes after epidural
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assitensial i Universitaria Manresa
state: Barcelona
Study officials:
References:
citation: ACOG Committee on Practice Bulletins. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 44, July 2003. (Replaces Committee Opinion Number 252, March 2001). Obstet Gynecol. 2003 Jul;102(1):203-13. No abstract available.
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citation: Lappen JR, Chien EK, Mercer BM. Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status. Obstet Gynecol. 2018 Oct;132(4):1011-1017. doi: 10.1097/AOG.0000000000002808.
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citation: Kubli M, Shennan AH, Seed PT, O'Sullivan G. A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour. Int J Obstet Anesth. 2003 Oct;12(4):256-60. doi: 10.1016/S0959-289X(03)00071-2.
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citation: Peyronnet V, Roses A, Girault A, Bonnet MP, Goffinet F, Tsatsaris V, Lecarpentier E. Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:94-99. doi: 10.1016/j.ejogrb.2017.10.016. Epub 2017 Oct 16.