Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)
1 februari 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
500
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 210004
- Nanjing Maternity and Child Health Care Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
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0.125% ropivacaine 10-15 ml every 1h during labor delivery
Andere namen:
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Actieve vergelijker: Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
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Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain scorings
Tijdsspanne: up to 3 days
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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.
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up to 3 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pruritus
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Dizziness
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Nausea
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Vomiting
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Drowsiness
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Sedation
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Respiratory depression
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Psychological effects
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Myoclonus
Tijdsspanne: From post-randomization to post-delivery day 3
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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
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Maternal heart rate
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Miosis
Tijdsspanne: From post-randomization to post-delivery day 3
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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.
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From post-randomization to post-delivery day 3
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Cesarean section
Tijdsspanne: The time at the end of the labor delivery
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Record the incidence of Cesarean section after completion of the labor delivery.
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The time at the end of the labor delivery
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to latent phase
Tijdsspanne: From the beginning of regular contraction of uterus to the dilation of cervical 4cm
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Record the time duration
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From the beginning of regular contraction of uterus to the dilation of cervical 4cm
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Time of active phase
Tijdsspanne: From the cervix 4cm to the dilation of cervical 10cm
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Record the time duration
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From the cervix 4cm to the dilation of cervical 10cm
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Overall satisfaction of analgesia
Tijdsspanne: At the time of the end of the labor delivery
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Assess the analgesia satisfaction after the completion of the labor delivery
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At the time of the end of the labor delivery
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Oxytocin usage
Tijdsspanne: At the time of the end of the labor
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Record the total usage of oxytocin after completion of the labor delivery
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At the time of the end of the labor
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Neonatal Apgar score
Tijdsspanne: At the time of the baby was born, 1min, 5min, 10min and 20min
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At the time of the baby was born, 1min, 5min, 10min and 20min
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Instrumental delivery
Tijdsspanne: At the time of the end of the labor
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Record the incidence of instrumental delivery after completion of the labor delivery.
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At the time of the end of the labor
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Umbilical gas analysis
Tijdsspanne: At the time of the fetus was delivery
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At the time of the fetus was delivery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2013
Primaire voltooiing (Werkelijk)
1 februari 2014
Studie voltooiing (Werkelijk)
1 februari 2014
Studieregistratiedata
Eerst ingediend
11 januari 2014
Eerst ingediend dat voldeed aan de QC-criteria
13 januari 2014
Eerst geplaatst (Schatting)
14 januari 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
4 februari 2014
Laatste update ingediend die voldeed aan QC-criteria
1 februari 2014
Laatst geverifieerd
1 februari 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Anesthesie, intraveneus
- Anesthesie, generaal
- Pijnstillers, opioïden
- Verdovende middelen
- Adjuvantia, anesthesie
- Anesthesie
- Anesthesie, lokaal
- Ropivacaine
- Sufentanil
Andere studie-ID-nummers
- NJFY13007
- JQX12009 (Ander subsidie-/financieringsnummer: Nanjing Municipal Bureau of Health)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .