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Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)

1. februar 2014 opdateret af: Fu Zhou Wang, Nanjing Medical University

Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control

It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

500

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210004
        • Nanjing Maternity and Child Health Care Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Nulliparas
  • Request epidural analgesia
  • Chinese

Exclusion Criteria:

  • Allergic to opioid or local anesthetics
  • Fail to perform epidural puncture and catheterization
  • Organ dysfunction
  • Contraindications for epidural anesthesia

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
Medicin: Ropivacain
Medicin: Sole local anesthetic
0.125% ropivacaine 10-15 ml every 1h during labor delivery
Andre navne:
  • Naropin
  • Ropivacain
Aktiv komparator: Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
Medicin: Ropivacain
Medicin: Sufentanil (Opioid plus local anesthetic)
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Andre navne:
  • Naropin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain scorings
Tidsramme: up to 3 days
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
up to 3 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pruritus
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Dizziness
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Nausea
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Vomiting
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Drowsiness
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Sedation
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Respiratory depression
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Psychological effects
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Myoclonus
Tidsramme: From post-randomization to post-delivery day 3

This describes muscle rigidity and abnormal movement of the limbs and muscles.

Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Maternal heart rate
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Miosis
Tidsramme: From post-randomization to post-delivery day 3
Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
From post-randomization to post-delivery day 3
Cesarean section
Tidsramme: The time at the end of the labor delivery
Record the incidence of Cesarean section after completion of the labor delivery.
The time at the end of the labor delivery

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to latent phase
Tidsramme: From the beginning of regular contraction of uterus to the dilation of cervical 4cm
Record the time duration
From the beginning of regular contraction of uterus to the dilation of cervical 4cm
Time of active phase
Tidsramme: From the cervix 4cm to the dilation of cervical 10cm
Record the time duration
From the cervix 4cm to the dilation of cervical 10cm
Overall satisfaction of analgesia
Tidsramme: At the time of the end of the labor delivery
Assess the analgesia satisfaction after the completion of the labor delivery
At the time of the end of the labor delivery
Oxytocin usage
Tidsramme: At the time of the end of the labor
Record the total usage of oxytocin after completion of the labor delivery
At the time of the end of the labor
Neonatal Apgar score
Tidsramme: At the time of the baby was born, 1min, 5min, 10min and 20min
At the time of the baby was born, 1min, 5min, 10min and 20min
Instrumental delivery
Tidsramme: At the time of the end of the labor
Record the incidence of instrumental delivery after completion of the labor delivery.
At the time of the end of the labor
Umbilical gas analysis
Tidsramme: At the time of the fetus was delivery
At the time of the fetus was delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

11. januar 2014

Først indsendt, der opfyldte QC-kriterier

13. januar 2014

Først opslået (Skøn)

14. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NJFY13007
  • JQX12009 (Andet bevillings-/finansieringsnummer: Nanjing Municipal Bureau of Health)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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