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Comparison of Two Methods of Administration of the Epidural, by Programmed Intermittent Bolus or Continuous Perfusion, on the Incidence of Cesarean Sections and Instrumented Deliveries in Primiparous Women

30. mai 2018 oppdatert av: Philippe VAN DER LINDEN, Brugmann University Hospital

The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.

Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).

In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.However, the optimal administration mode of the local anesthetic in the epidural remains unknown.

In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.

This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.

The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.

Studieoversikt

Detaljert beskrivelse

The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.

Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).

In 2001, the COMET study showed that the use of low anesthetics concentrations decreases the motor bloc and allows to increase the rate of vaginal deliveries and decrease the rate of instrumented births.

In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.

However, the optimal administration mode of the local anesthetic in the epidural remains unknown.

In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.

Several studies have been performed and show that this mode of administration allows to decrease the local anesthetics injected dosis and gives a better maternal satisfaction. A meta-analysis performed in 2013 also shows a tendency towards the decrease of instrumented deliveries with this method. Sadly, no studies up to this date have the needed power to prove this point with certainty.

This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.

The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Brussels, Belgia, 1020
        • CHU Brugmann

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Women over 18 years of age
  • Primiparous
  • Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
  • Written informed consent
  • Cervical dilatation between 3 and 6 cm at recruitment
  • Single pregnancy
  • Foetus in cephalic position

Exclusion Criteria:

  • Participation refusal or epidural contra-indication
  • Multiparous
  • Allergy to the products used
  • Twin pregnancy
  • Height <1m55 and/or narrow pelvis, as shown by imagery
  • Language barrier
  • Patients with a BMI superior or equal to 35 (computed with the weight at the beginning of the pregnancy)
  • Cervical dilatation at recruitment <3 or >6 cm
  • ASA score (American Society of Anesthesiologists) 3 or 4
  • Foetus in transverse or seat position

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Programmed intermittent boluses
Epidural analgesia performed with programmed intermittent boluses.
Injection of programmed intermittent boluses in the epidural space, without continuous perfusion, of the same solution (Chirocaine 0.07% + Sufentanil 0.3 mcg/ml): 10ml each 60 minutes
Aktiv komparator: Continuous perfusion
Epidural analgesia performed with a continuous perfusion.
Continuous epidural perfusion: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml with a 10ml/hour rate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of instrumented deliveries (suction pumps, forceps)
Tidsramme: 24h after the baby's birth
Number of deliveries requiring instrumentation (suction pumps, forceps)
24h after the baby's birth
Rate of cesarian sections
Tidsramme: 24h after the baby's birth
Number of deliveries requiring a cesarian section
24h after the baby's birth

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of anesthesist interventions
Tidsramme: Starting from the first injection of the epidural till the baby's birth
Number of visits of the anesthesist, either requested by the patient (request for additional analgesia by the patient because of pain during labor: the pain itself is not measured), either necessary because of side effects (nausea, pruritus).
Starting from the first injection of the epidural till the baby's birth
Maternal satisfaction
Tidsramme: 24h after the baby's birth
Will be assessed by means of a questionnaire (0 to 100 visual scale)
24h after the baby's birth
Presence of a motor block
Tidsramme: At the precise moment when the cervix reaches complete dilatation (10 cm opening) during labor
Assessed by the anesthesist with the Bromage modified scale
At the precise moment when the cervix reaches complete dilatation (10 cm opening) during labor

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mars 2016

Primær fullføring (Faktiske)

20. mars 2018

Studiet fullført (Faktiske)

20. mars 2018

Datoer for studieregistrering

Først innsendt

2. mars 2016

Først innsendt som oppfylte QC-kriteriene

7. mars 2016

Først lagt ut (Anslag)

11. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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