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Anesthesia, ObstetricalPhase 3PIEBvsPCEANCT03133091

Epidural Analgesia During Labour

A Phase 3 study testing PIEB: Patient Intermittent Epidural Boluses in people with Anesthesia, Obstetrical and Analgesia, Epidural, run by Hospital del Rio Hortega at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anesthesia, Obstetrical, Analgesia, Epidural
What is being tested?
PIEB: Patient Intermittent Epidural Boluses
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
Sep 2015to Sep 2017
Phase
Phase 3
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 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
PIEB: Patient Intermittent Epidural Boluses, PCEA: Patient Controlled Epidural Analgesia
Keywords
PIEB, PCEA, LEVOBUPIVACAINE
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PIEB: Patient Intermittent Epidural BolusesDrug

    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).

  • PCEA: Patient Controlled Epidural AnalgesiaDrug

    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).

Study groups in NCT03133091
Study groupRoleWhat they receive
PIEB (Patient Intermittent Epidural Bolus)Active comparatorPIEB: 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.
Receives: Drug: PIEB: Patient Intermittent Epidural Boluses
PCEA (Patient continuous Epidural Analgesia)Active comparatorPCEA: 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.
Receives: Drug: PCEA: Patient Controlled Epidural Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS

    Change from baseline in Visual Analog Scale

    Measured: 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery

Secondary outcomes (10)

  1. Satisfaction (Likert Scale)

    1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)

    Measured: 1 hour after delivery

  2. Bromage Scale

    Measured: 15 minutes after Epidural Block and 1 hour after epidural block

  3. Labour Outcome

    Eutocic

    Measured: Delivery

  4. Labour Outcome

    instrumental

    Measured: Delivery

  5. Labour Outcome

    cesarean section

    Measured: Delivery

  6. Expulsive time

    Measured: From 10 cm of dilatation until delivery

  7. Apgar at birth

    Apgar measured in 1 minute

    Measured: 1 minute after birth

  8. Apgar at birth

    Apgar measured in 5 minutes

    Measured: 5 minutes after birth

  9. fetal pH at birth

    0 minutes after delivery

    Measured: 0 minutes after delivery

  10. Total Dosis of Levobupivacaine

    miligrams

    Measured: 0 minutes after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study startSep 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03133091
Sponsor's protocol ID
290587
Acronym
PIEBvsPCEA
Status last verified
Aug 2018
First submitted
12 Sep 2016
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 23223119

  • 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.

    PubMed 16492849

  • 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.

    PubMed 21788309

  • 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.

    PubMed 15197122

  • 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.

    PubMed 27471390

  • Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f.

    PubMed 19224805

  • 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.

    PubMed 24659334

  • 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.

    PubMed 6384895

  • 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.

    PubMed 14995921

  • 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.

    PubMed 22419342

  • 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.

    PubMed 22112332

  • 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.

    PubMed 8942841

  • 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.

    PubMed 15659468

  • 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.

    PubMed 21621130

  • 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.

    PubMed 30506299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PIEB: Patient Intermittent Epidural Boluses in people with Anesthesia, Obstetrical and Analgesia, Epidural, run by Hospital del Rio Hortega 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 6 inclusion and 6 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 6 Aug 2018. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

VAS (time frame: 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery). 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 NCT03133091, which also lists 15 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 6 Aug 2018.

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