Epidural Analgesia During Labour (PIEBvsPCEA)

Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine

Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Obstetrical; Analgesia, Epidural
• Intervention / Treatment: Drug: PIEB: Patient Intermittent Epidural Boluses; Drug: PCEA: Patient Controlled Epidural Analgesia

Detailed Description

There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 20- 40 years-old women
• Primiparous women
• Dilatation 3- 7 cm
• No risk illnesses for epidural block
• No risk pregnancy
• Signed informed consent

Exclusion Criteria:

• Illnesses which are a risk for pregnancy
• Multiparous women
• Contraindicated diseases for epidural block
• Women who can not understand the procedure
• Women who do not want to sign the informed consent
• Patients with drug´s allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PIEB (Patient Intermittent Epidural Bolus); PIEB: The boluses are programmed every 30 minutes. The patient can ask for another extra bolus in between if she wishes. The dosis per hour are equivalent to the PCEA. We make a comparison between PCEA vs PIEB.	Drug: PIEB: Patient Intermittent Epidural Boluses; Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
Active Comparator: PCEA (Patient continuous Epidural Analgesia); PCEA: There is a continuous infusion and the patient can order extra boluses every 15 minutes. The dosis per hour are equivalent to the other arm to the PIEB. We make a comparison between PCEA vs PIEB.	Drug: PCEA: Patient Controlled Epidural Analgesia; Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Change from baseline in Visual Analog Scale	4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction (Likert Scale)	1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)	1 hour after delivery
Bromage Scale		15 minutes after Epidural Block and 1 hour after epidural block
Labour Outcome	Eutocic	Delivery
Labour Outcome	instrumental	Delivery
Labour Outcome	cesarean section	Delivery
Expulsive time		From 10 cm of dilatation until delivery
Apgar at birth	Apgar measured in 1 minute	1 minute after birth
Apgar at birth	Apgar measured in 5 minutes	5 minutes after birth
fetal pH at birth	0 minutes after delivery	0 minutes after delivery
Total Dosis of Levobupivacaine	miligrams	0 minutes after delivery

Collaborators and Investigators

• Sponsor: Hospital del Rio Hortega
• Investigators: Study Director: M BELEN RODRIGUEZ-CAMPOO, Resident

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.
• Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
• Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.
• Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.
• Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016 Jul 14;12:1107-12. doi: 10.2147/TCRM.S106021. eCollection 2016.
• Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f.
• Gizzo S, Noventa M, Fagherazzi S, Lamparelli L, Ancona E, Di Gangi S, Saccardi C, D'Antona D, Nardelli GB. Update on best available options in obstetrics anaesthesia: perinatal outcomes, side effects and maternal satisfaction. Fifteen years systematic literature review. Arch Gynecol Obstet. 2014 Jul;290(1):21-34. doi: 10.1007/s00404-014-3212-x.
• Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-337. doi: 10.1016/0304-3959(84)90079-4. No abstract available.
• Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.
• Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
• Eriksen LM, Nohr EA, Kjaergaard H. Mode of delivery after epidural analgesia in a cohort of low-risk nulliparas. Birth. 2011 Dec;38(4):317-26. doi: 10.1111/j.1523-536X.2011.00486.x. Epub 2011 Sep 6.
• Lieberman E, Lang JM, Cohen A, D'Agostino R Jr, Datta S, Frigoletto FD Jr. Association of epidural analgesia with cesarean delivery in nulliparas. Obstet Gynecol. 1996 Dec;88(6):993-1000. doi: 10.1016/s0029-7844(96)00359-6.
• Patel RR, Peters TJ, Murphy DJ; ALSPAC Study Team. Prenatal risk factors for Caesarean section. Analyses of the ALSPAC cohort of 12,944 women in England. Int J Epidemiol. 2005 Apr;34(2):353-67. doi: 10.1093/ije/dyh401. Epub 2005 Jan 19.
• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
• Rodriguez-Campoo MB, Curto A, Gonzalez M, Aldecoa C. Patient intermittent epidural boluses (PIEB) plus very low continuous epidural infusion (CEI) versus patient-controlled epidural analgesia (PCEA) plus continuous epidural infusion (CEI) in primiparous labour: a randomized trial. J Clin Monit Comput. 2019 Oct;33(5):879-885. doi: 10.1007/s10877-018-0229-x. Epub 2018 Nov 30.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: PIEB; PCEA; LEVOBUPIVACAINE
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 290587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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