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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systemic vascular resistance ( units of measure:dyn*s/cm5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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
研究组 & 干预措施
Levobupivacaina
Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour
干预措施: Levobupivacaine (Drug)
Ropivacaina
Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Systemic vascular resistance ( units of measure:dyn*s/cm5)
时间窗: 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.
Systemic vascular resistance ( units of measure :dyn*s/cm5)
时间窗: 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.
次要结局
- Pulse Pressure (units of measure :mmHg)(60 minutes after epidural)
- Cardiac Output (units of measure :L/min)(60 minutes after epidural)
- Arterial Oxigen Saturation ( units of measure :% Percent)(60 minutes after epidural)
- Stroke Volume (units of measure :ml)(60 minutes after epidural)
- Fetal heart rate (units of measure: beats per minute)(60 minutes after epidural)
- Decelerations (units of measure: beats per minute)(60 minutes after epidural)
- Mean Arterial Pressure (units of measure :mmHg)(60 minutes after epidural)
- Cardiac Index ( units of measure :L/min/m2)(60 minutes after epidural)
- Diastolic Blood Pressure (units of measure :mmHg)(60 minutes after epidural)
- Pulse Pressure Variation ( units of measure :% Percent)(60 minutes after epidural)
- Variability (units of measure: beats per minute)(60 minutes after epidural)
- Systolic Blood Pressure (units of measure :mmHg)(60 minutes after epidural)
- (Maternal) Heart Rate (units of measure: beats per minute)(60 minutes after epidural)
- Systolic Variation Volume ( units of measure :% Percent)(60 minutes after epidural)
- Accelerations (units of measure: beats per minute)(60 minutes after epidural)
研究者
Mauricio Roberto Argañaraz Quinteros
Physician
Althaia Xarxa Assistencial Universitària de Manresa
