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

NCT03839056 | Completed

• 1 other identifier: MAR-ROP-2015-01
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Labor Epidural Analgesia

Keywords

epidural local anesthetic; epidural analgesia; analgesia labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• analgesic effectiveness with AVE

  Baseline (just after epidural administration)

• analgesic effectiveness with AVE

  15 minutes after epidural administration

• analgesic effectiveness with AVE

  30 minutes after epidural administration

• analgesic effectiveness with AVE

  every 2 hours until the end of labor

• Motor blockade from zero to four

  Baseline (just after epidural administration)

Other Outcomes (6)

• Weight in kilograms

  Just before epidural administration

• Size in centimeters

  Just before epidural administration

• ASA from one to five

  Just before epidural administration

Study Arms (3)

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

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

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

Interventions

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

IC+PIEB+PCEA high flow

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 high flow

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

PIEB+PCEA standar flow

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marian Daras: lead
• Hospital Universitario de la Plana: collaborator

Study Sites (1)

Hospital Universitario de La Plana

Villarreal, Castellón, 12540, Spain

Location

Related Publications (17)

• 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.

  PMID: 10204896 BACKGROUND

• 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.

  PMID: 10834779 BACKGROUND

• 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.

  PMID: 23076897 BACKGROUND

• 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.

  PMID: 24738803 BACKGROUND

• 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.

  PMID: 29781504 BACKGROUND

• 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.

  PMID: 12409932 BACKGROUND

• 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.

  PMID: 10201661 BACKGROUND

• 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.

  PMID: 10475309 BACKGROUND

• 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.

  PMID: 17717236 BACKGROUND

• 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.

  PMID: 23223119 BACKGROUND

• 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.

  PMID: 27464978 BACKGROUND

• 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.

  PMID: 27755057 BACKGROUND

• 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.

  PMID: 28875709 BACKGROUND

• 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.

  PMID: 29770432 BACKGROUND

• 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.

  PMID: 27687462 BACKGROUND

• 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.

  PMID: 31743179 BACKGROUND

• 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.

  PMID: 21320088 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: August 2, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)