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.

Study Overview

• Status: Completed
• Conditions: Labor Epidural Analgesia
• Intervention / Treatment: Device: IC+PIEB+PCEA high flow; Device: PIEB+PCEA high flow; Device: PIEB+PCEA standar flow

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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Spain
  • Castellón
    • Villarreal, Castellón, Spain, 12540
      • Hospital Universitario de La Plana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: IC+PIEB+PCEA high flow; 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; 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; 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; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kilograms	The weight in kilograms will be noted on the epidural record sheet	Just before epidural administration
Size in centimeters	The height in centimeters will be noted on the epidural record sheet	Just before epidural administration
ASA from one to five	The ASA classification will be noted on the epidural record sheet	Just before epidural administration
Gestational week in number	The Gestational week in number will be noted on the epidural record sheet	Just before epidural administration
Cervical dilatation at the time of performing the epidural technique in centimeters	The dilatation in centimeters will be noted on the epidural record sheet	Just before epidural administration
Administration of parenteral opioids and the time of 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	Just before epidural administration

Collaborators and Investigators

• Sponsor: Marian Daras
• Collaborators: Hospital Universitario de la Plana

Publications and helpful links

General Publications

• George 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. Erratum In: Anesth Analg. 2013 Jun;116(6):1385.
• Patel 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.
• Anim-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.
• 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.
• Beaubien 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.
• Simmons 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.
• Birnbach 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.
• Polley 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.
• Johnson 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.
• Beilin 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.
• Carvalho 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.
• Epsztein 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.
• Delgado 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.
• Sng 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.
• Klumpner 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.
• Krawczyk P, Piwowar P, Salapa K, Lonc T, Andres J. Do Epidural Catheter Size and Flow Rate Affect Bolus Injection Pressure in Different Programmed Intermittent Epidural Bolus Regimens? An In Vitro Study. Anesth Analg. 2019 Dec;129(6):1587-1594. doi: 10.1213/ANE.0000000000003650.
• Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2015
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: epidural analgesia; epidural local anesthetic; analgesia labor
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: MAR-ROP-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No