Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia

Study Overview
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Brief Summary
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The investigators have design an observational study to know the anesthetic consumption in terms of rescue analgesia (Patient Controlled Epidural Analgesia (PCEA) and manual boluses) of the combination of different modes of administration of local anesthetic in the epidural space during labor analgesia offered by the new version of the CADD® infusion pump. Also in this pump the anesthetic can be administered across a system of standard flow (40-250ml/h) or of high flow (40-500ml/h), what according to studies can influence the diffusion epidural of the anesthetic and therefore the level of sensitive blockade.

Detailed Description
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The study is designed with healthy patients, first-time mothers, in childbearing dynamics, term pregnancy and nullipary. The epidural technique was performed with dose test of 3ml of bupivacaína 0,25 % with vasoconstrictor and a manual bolus of 0,1ml/Kg of ropivacaína 0,2% with fentanilo 5ug/ml. As soon as the informed consent about the epidural anesthesia was signed, the patient was informed of the possibility of taking part in the study and there is offered him the sheet of information of the patient. So in one group they were administered Programed Intermittent Epidural Boluses (PIEB) and in other group continuous Epidural Infusion (IC) plus PIEB according to the usual clinical practice of each anesthesiologist. In both cases the perfusion was of ropivacaína 0,1 % more fentanilo 2ug/ml, so that in the first group it was administered PIEB of 10ml every hour and in the second group a continuous infusion to 3ml/h plus PIEB of 7ml every hour. Also if during the period of dilatation an AVE (Analogical Visual Escale) greater than or equal to 4 appeared (inadequate analgesia) the patient could administer a 5ml PCEA bolus of the same solution (interval of closing of 20min and maximum dose for hour of 15ml), as it is done in according to the usual clinical practice. And if after two boluses of PCEA the analgesia was still ineffective a clinical bolus of 4ml of lidocaína to 1 % was administered by the anesthesiologist. In addition, in the group that was administered only PIEB, the standard infusion system was compared with the high-flow infusion system. In all patients it was evaluated and noted on the epidural record sheet the intensity of the pain as the analogical visual scale (AVE), the grade of motor blockade as the modified scale of Bromage and the sensitive level in different periods of time. Also registered the total doses of anesthetic, the way of the childbearing finishes, the Apgar of the newborn, the grade of maternal satisfaction and the side effects. Also through the software of the pump it was verified if the patient had been administered rescue analgesia (PCEA or clinical boluses).

Official Title
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Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia

Conditions
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Labor Epidural Analgesia

Intervention / Treatment
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* Device: IC+PIEB+PCEA high flow
* Device: PIEB+PCEA high flow
* Device: PIEB+PCEA standar flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in work of established labor and contractions of moderate intensity Age between 18 and 45 years ASA I and II Nulliparity Pregnancy to term (> 36semanas) The only fetus of cephalic presentation Cervical dilation between 2-5cm Exclusion Criteria: Maternal systemic illness (Diabetes Mellitus, arterial Hypertension, Preeclampsia. . ) Major or equal weight to 100 Kg Less height of 150cm Duration of the equal or major childbearing to 24h Administration of opioides parenterales in 2-4h before to performing of the epidural Contraindication for neuroaxial analgesia Precedents of allergy or hypersensitivity to anesthetic local

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IC+PIEB+PCEA high flow<br>Continuous Epidural Infusion to 3ml/h more Programed Intermittent Epidural Boluses of 7ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine | Device: IC+PIEB+PCEA high flow<br>* Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution. If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated. If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %. This intervention is included in the clinical practice routine<br>|
| PIEB+PCEA high flow<br>Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine | Device: PIEB+PCEA high flow<br>* Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution. If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated. If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %. In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared. This intervention is included in the clinical practice routine<br>|
| PIEB+PCEA standar flow<br>Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of standar flow as clinical practice routine | Device: PIEB+PCEA standar flow<br>* Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution. If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated. If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %. In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared. This intervention is included in the clinical practice routine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anesthetic consumption in milliliters | The anesthetic consumption in terms of analgesia of rescue of the combination of different ways of administration of anesthetic in the space epidural. The quantity of extra analgesic is already by means of boluses of PCEA or by means of clinical boluses measured in milliliters | at the end of labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic effectiveness with AVE | Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10 | Baseline (just after epidural administration) | 
| analgesic effectiveness with AVE | Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10 | 15 minutes after epidural administration | 
| analgesic effectiveness with AVE | Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10 | 30 minutes after epidural administration | 
| analgesic effectiveness with AVE | Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10 | every 2 hours until the end of labor | 
| Motor blockade from zero to four | The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3): 0 = it can raise the low extremities of the bed = it can bend knees and ankles = it can bend ankles but not the knees = it can bend neither ankles nor knees | Baseline (just after epidural administration) | 
| Motor blockade from zero to four | The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3): 0 = it can raise the low extremities of the bed = it can bend knees and ankles = it can bend ankles but not the knees = it can bend neither ankles nor knees | 15 minutes after epidural administration | 
| Motor blockade from zero to four | The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3): 0 = it can raise the low extremities of the bed = it can bend knees and ankles = it can bend ankles but not the knees = it can bend neither ankles nor knees | 30 minutes after epidural administration | 
| Motor blockade from zero to four | The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3): 0 = it can raise the low extremities of the bed = it can bend knees and ankles = it can bend ankles but not the knees = it can bend neither ankles nor knees | every 2 hours until the end of labor | 
| Sensitive blockade from T12 to T4 | The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8). | Baseline (just after epidural administration) | 
| Sensitive blockade from T12 to T4 | The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region ). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8). | 15 minutes after epidural administration | 
| Sensitive blockade from T12 to T4 | The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8). | 30 minutes after epidural administration | 
| Sensitive blockade from T12 to T4 | The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8). | every 2 hours until the end of labor | 
| Blood pressure | The patient will be evaluated and there will register the blood pressure in mm of mercury | Baseline (just after epidural administration) | 
| Blood pressure | The patient will be evaluated and there will register the blood pressure in mm of mercury | 15 minutes after epidural administration | 
| Blood pressure | The patient will be evaluated and there will register the blood pressure in mm of mercury | 30 minutes after epidural administration | 
| Blood pressure | The patient will be evaluated and there will register the blood pressure in mm of mercury | every 2 hours until the end of labor | 
| Maternal heart rate | The patient will be evaluated and there will register the maternal heart rate in beats per minute | Baseline (just after epidural administration) | 
| Maternal heart rate | The patient will be evaluated and there will register the maternal heart rate in beats per minute | 15 minutes after epidural administration | 
| Maternal heart rate | The patient will be evaluated and there will register the maternal heart rate in beats per minute | 30 minutes after epidural administration | 
| Maternal heart rate | The patient will be evaluated and there will register the maternal heart rate in beats per minute | every 2 hours until the end of labor | 
| maternal satisfaction | On having finished the childbearing, from 0 to 100 will value the grade of maternal satisfaction as an evaluation scale: 0 = very unsatisfied with the analgesia provided by the treatment 100 = extremely satisfied with the analgesia provided by the treatment | at the end of labor | 
| adverse effects | There will be noted down also the appearance of adverse effects as the sickness and vomiting, urinal retention, pruritus and fever. | at the end of labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural local anesthetic, epidural analgesia, analgesia labor