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Completed

NCT Number: NCT03839056

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

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.

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Key information

Conditions

Labor Epidural Analgesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario de La Plana

Villarreal, Castellón, 12540, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IC+PIEB+PCEA high flow

Device

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

PIEB+PCEA high flow

Device

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

PIEB+PCEA standar flow

Device

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

Primary outcomes

  1. anesthetic consumption in milliliters

    Time frame: at the end of labour

    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

Secondary outcomes

  1. analgesic effectiveness with AVE

    Time frame: Baseline (just after epidural administration)

    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

  2. analgesic effectiveness with AVE

    Time frame: 15 minutes after epidural administration

    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

  3. analgesic effectiveness with AVE

    Time frame: 30 minutes after epidural administration

    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

  4. analgesic effectiveness with AVE

    Time frame: every 2 hours until the end of labor

    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

  5. Motor blockade from zero to four

    Time frame: Baseline (just after epidural administration)

    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

  6. Motor blockade from zero to four

    Time frame: 15 minutes after epidural administration

    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

  7. Motor blockade from zero to four

    Time frame: 30 minutes after epidural administration

    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

  8. Motor blockade from zero to four

    Time frame: every 2 hours until the end of labor

    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

  9. Sensitive blockade from T12 to T4

    Time frame: Baseline (just after epidural administration)

    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).

  10. Sensitive blockade from T12 to T4

    Time frame: 15 minutes after epidural administration

    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).

  11. Sensitive blockade from T12 to T4

    Time frame: 30 minutes after epidural administration

    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).

  12. Sensitive blockade from T12 to T4

    Time frame: every 2 hours until the end of labor

    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).

  13. Blood pressure

    Time frame: Baseline (just after epidural administration)

    The patient will be evaluated and there will register the blood pressure in mm of mercury

  14. Blood pressure

    Time frame: 15 minutes after epidural administration

    The patient will be evaluated and there will register the blood pressure in mm of mercury

  15. Blood pressure

    Time frame: 30 minutes after epidural administration

    The patient will be evaluated and there will register the blood pressure in mm of mercury

  16. Blood pressure

    Time frame: every 2 hours until the end of labor

    The patient will be evaluated and there will register the blood pressure in mm of mercury

  17. Maternal heart rate

    Time frame: Baseline (just after epidural administration)

    The patient will be evaluated and there will register the maternal heart rate in beats per minute

  18. Maternal heart rate

    Time frame: 15 minutes after epidural administration

    The patient will be evaluated and there will register the maternal heart rate in beats per minute

  19. Maternal heart rate

    Time frame: 30 minutes after epidural administration

    The patient will be evaluated and there will register the maternal heart rate in beats per minute

  20. Maternal heart rate

    Time frame: every 2 hours until the end of labor

    The patient will be evaluated and there will register the maternal heart rate in beats per minute

  21. maternal satisfaction

    Time frame: at the end of labor

    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

  22. adverse effects

    Time frame: at the end of labor

    There will be noted down also the appearance of adverse effects as the sickness and vomiting, urinal retention, pruritus and fever.

Other outcomes

  1. Weight in kilograms

    Time frame: Just before epidural administration

    The weight in kilograms will be noted on the epidural record sheet

  2. Size in centimeters

    Time frame: Just before epidural administration

    The height in centimeters will be noted on the epidural record sheet

  3. ASA from one to five

    Time frame: Just before epidural administration

    The ASA classification will be noted on the epidural record sheet

  4. Gestational week in number

    Time frame: Just before epidural administration

    The Gestational week in number will be noted on the epidural record sheet

  5. Cervical dilatation at the time of performing the epidural technique in centimeters

    Time frame: Just before epidural administration

    The dilatation in centimeters will be noted on the epidural record sheet

  6. Administration of parenteral opioids and the time of administration

    Time frame: Just before epidural administration

    In the epidural record sheet if opioids have been administered it will be recorded as YES and if they have not been administered it will be recorded as NO. If it has been administered, the time of its admnistracion will be indicated numerically

Sponsors and collaborators

Lead sponsor

Marian Daras

Other

Collaborators

  • Hospital Universitario de la Plana

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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