Labor Epidural AnalgesiaNCT03839056
Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia
An observational study of Labor Epidural Analgesia, run by Marian Daras at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Epidural Analgesia
- What is being tested?
- IC+PIEB+PCEA high flow, PIEB+PCEA high flow and PIEB+PCEA standar flow
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 151 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2015to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will be realized in women in work of labor who come our hospital and who after being valued by the team of obstetrics are in favorable active period for the achievement of the technique epidural previous informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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).
- Conditions
- Labor Epidural Analgesia
- Being tested
- IC+PIEB+PCEA high flow, PIEB+PCEA high flow, PIEB+PCEA standar flow
- Keywords
- epidural local anesthetic, epidural analgesia, analgesia labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC+PIEB+PCEA high flowDevice
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 flowDevice
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 flowDevice
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
| Study group | Role | What they receive |
|---|---|---|
| IC+PIEB+PCEA high flow | 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 Receives: Device: IC+PIEB+PCEA high flow | |
| PIEB+PCEA high flow | 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 Receives: Device: PIEB+PCEA high flow | |
| PIEB+PCEA standar flow | 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 Receives: Device: PIEB+PCEA standar flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of labour
Secondary outcomes (22)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Baseline (just after epidural administration)
Blood pressure
The patient will be evaluated and there will register the blood pressure in mm of mercury
Measured: 15 minutes after epidural administration
Blood pressure
The patient will be evaluated and there will register the blood pressure in mm of mercury
Measured: 30 minutes after epidural administration
Blood pressure
The patient will be evaluated and there will register the blood pressure in mm of mercury
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at the end of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start2 Aug 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Labor Epidural AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marian Daras
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de la Plana
- Responsible party
- Sponsor-investigator, Marian Daras, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839056
- Sponsor's protocol ID
- MAR-ROP-2015-01
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albright GA, Forster RM. The safety and efficacy of combined spinal and epidural analgesia/anesthesia (6,002 blocks) in a community hospital. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):117-25. doi: 10.1016/s1098-7339(99)90071-8.
PubMed 10204896Beaubien G, Drolet P, Girard M, Grenier Y. Patient-controlled epidural analgesia with fentanyl-bupivacaine: influence of prior dural puncture. Reg Anesth Pain Med. 2000 May-Jun;25(3):254-8. doi: 10.1016/s1098-7339(00)90007-5.
PubMed 10834779Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
PubMed 23076897Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.
PubMed 24738803Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
PubMed 29781504Birnbach DJ, Ojea LS. Combined spinal-epidural (CSE) for labor and delivery. Int Anesthesiol Clin. 2002 Fall;40(4):27-48. doi: 10.1097/00004311-200210000-00005. No abstract available.
PubMed 12409932Polley LS, Columb MO, Naughton NN, Wagner DS, van de Ven CJ. Relative analgesic potencies of ropivacaine and bupivacaine for epidural analgesia in labor: implications for therapeutic indexes. Anesthesiology. 1999 Apr;90(4):944-50. doi: 10.1097/00000542-199904000-00003.
PubMed 10201661Johnson RF, Cahana A, Olenick M, Herman N, Paschall RL, Minzter B, Ramasubramanian R, Gonzalez H, Downing JW. A comparison of the placental transfer of ropivacaine versus bupivacaine. Anesth Analg. 1999 Sep;89(3):703-8. doi: 10.1097/00000539-199909000-00032.
PubMed 10475309Beilin Y, Guinn NR, Bernstein HH, Zahn J, Hossain S, Bodian CA. Local anesthetics and mode of delivery: bupivacaine versus ropivacaine versus levobupivacaine. Anesth Analg. 2007 Sep;105(3):756-63. doi: 10.1213/01.ane.0000278131.73472.f4.
PubMed 17717236George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
PubMed 23223119Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg. 2016 Oct;123(4):965-71. doi: 10.1213/ANE.0000000000001407.
PubMed 27464978Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.
PubMed 27755057Delgado C, Ciliberto C, Bollag L, Sedensky M, Landau R. Continuous epidural infusion versus programmed intermittent epidural bolus for labor analgesia: optimal configuration of parameters to reduce physician-administered top-ups. Curr Med Res Opin. 2018 Apr;34(4):649-656. doi: 10.1080/03007995.2017.1377166. Epub 2017 Oct 6.
PubMed 28875709Sng BL, Zeng Y, de Souza NNA, Leong WL, Oh TT, Siddiqui FJ, Assam PN, Han NR, Chan ES, Sia AT. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. Cochrane Database Syst Rev. 2018 May 17;5(5):CD011344. doi: 10.1002/14651858.CD011344.pub2.
PubMed 29770432Klumpner TT, Lange EM, Ahmed HS, Fitzgerald PC, Wong CA, Toledo P. An in vitro evaluation of the pressure generated during programmed intermittent epidural bolus injection at varying infusion delivery speeds. J Clin Anesth. 2016 Nov;34:632-7. doi: 10.1016/j.jclinane.2016.06.017. Epub 2016 Aug 3.
PubMed 27687462
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia
- ClinicalTrials.gov ID
- NCT03839056
- Acronym / sponsor ID
- MAR-ROP-2015-01
- Conditions
- Labor Epidural Analgesia
- Keywords
- epidural local anesthetic, epidural analgesia, analgesia labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Marian DarasUniversity, hospital or other
- Collaborators
- Hospital Universitario de la Plana
- Study start
- 2 Aug 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IC+PIEB+PCEA high flow | – | Device: IC+PIEB+PCEA high flowContinuous 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 |
| PIEB+PCEA high flow | – | Device: PIEB+PCEA high flowProgramed 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 |
| PIEB+PCEA standar flow | – | Device: PIEB+PCEA standar flowProgramed 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will be realized in women in work of labor who come our hospital and who after being valued by the team of obstetrics are in favorable active period for the achievement of the technique epidural previous informed consent.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC+PIEB+PCEA high flowRopivacaina 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 | Device | IC+PIEB+PCEA high flow |
| PIEB+PCEA high flowRopivacaina 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 | Device | PIEB+PCEA high flow |
| PIEB+PCEA standar flowRopivacaina 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 | Device | PIEB+PCEA standar flow |
Primary outcome
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
22 secondary outcomes
analgesic effectiveness with AVE
Time frame: Baseline (just after epidural administration)
analgesic effectiveness with AVE
Time frame: 15 minutes after epidural administration
analgesic effectiveness with AVE
Time frame: 30 minutes after epidural administration
analgesic effectiveness with AVE
Time frame: every 2 hours until the end of labor
Motor blockade from zero to four
Time frame: Baseline (just after epidural administration)
Motor blockade from zero to four
Time frame: 15 minutes after epidural administration
Motor blockade from zero to four
Time frame: 30 minutes after epidural administration
Motor blockade from zero to four
Time frame: every 2 hours until the end of labor
Sensitive blockade from T12 to T4
Time frame: Baseline (just after epidural administration)
Sensitive blockade from T12 to T4
Time frame: 15 minutes after epidural administration
Sensitive blockade from T12 to T4
Time frame: 30 minutes after epidural administration
Sensitive blockade from T12 to T4
Time frame: every 2 hours until the end of labor
Blood pressure
Time frame: Baseline (just after epidural administration)
Blood pressure
Time frame: 15 minutes after epidural administration
Blood pressure
Time frame: 30 minutes after epidural administration
Blood pressure
Time frame: every 2 hours until the end of labor
Maternal heart rate
Time frame: Baseline (just after epidural administration)
Maternal heart rate
Time frame: 15 minutes after epidural administration
Maternal heart rate
Time frame: 30 minutes after epidural administration
Maternal heart rate
Time frame: every 2 hours until the end of labor
maternal satisfaction
Time frame: at the end of labor
adverse effects
Time frame: at the end of labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 10204896Albright GA, Forster RM. The safety and efficacy of combined spinal and epidural analgesia/anesthesia (6,002 blocks) in a community hospital. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):117-25. doi: 10.1016/s1098-7339(99)90071-8.
- Background: PubMed 10834779Beaubien G, Drolet P, Girard M, Grenier Y. Patient-controlled epidural analgesia with fentanyl-bupivacaine: influence of prior dural puncture. Reg Anesth Pain Med. 2000 May-Jun;25(3):254-8. doi: 10.1016/s1098-7339(00)90007-5.
- Background: PubMed 23076897Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
- Background: PubMed 24738803Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.
- Background: PubMed 29781504Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
- Background: PubMed 12409932Birnbach DJ, Ojea LS. Combined spinal-epidural (CSE) for labor and delivery. Int Anesthesiol Clin. 2002 Fall;40(4):27-48. doi: 10.1097/00004311-200210000-00005. No abstract available.
- Background: PubMed 10201661Polley LS, Columb MO, Naughton NN, Wagner DS, van de Ven CJ. Relative analgesic potencies of ropivacaine and bupivacaine for epidural analgesia in labor: implications for therapeutic indexes. Anesthesiology. 1999 Apr;90(4):944-50. doi: 10.1097/00000542-199904000-00003.
- Background: PubMed 10475309Johnson RF, Cahana A, Olenick M, Herman N, Paschall RL, Minzter B, Ramasubramanian R, Gonzalez H, Downing JW. A comparison of the placental transfer of ropivacaine versus bupivacaine. Anesth Analg. 1999 Sep;89(3):703-8. doi: 10.1097/00000539-199909000-00032.
- Background: PubMed 17717236Beilin Y, Guinn NR, Bernstein HH, Zahn J, Hossain S, Bodian CA. Local anesthetics and mode of delivery: bupivacaine versus ropivacaine versus levobupivacaine. Anesth Analg. 2007 Sep;105(3):756-63. doi: 10.1213/01.ane.0000278131.73472.f4.
- Background: PubMed 23223119George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
- Background: PubMed 27464978Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg. 2016 Oct;123(4):965-71. doi: 10.1213/ANE.0000000000001407.
- Background: PubMed 27755057Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Epidural Analgesia, run by Marian Daras at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anesthetic consumption in milliliters (time frame: at the end of labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839056, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.