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

1 février 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

500

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
Médicament: Ropivacaïne
Médicament: Sole local anesthetic
0.125% ropivacaine 10-15 ml every 1h during labor delivery
Autres noms:
  • Naropine
  • Ropivacaïne
Comparateur actif: Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
Médicament: Ropivacaïne
Médicament: Sufentanil (Opioid plus local anesthetic)
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Autres noms:
  • Naropine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain scorings
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pruritus
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Time to latent phase
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: At the time of the fetus was delivery
At the time of the fetus was delivery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nanjing Medical University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2013

Achèvement primaire (Réel)

1 février 2014

Achèvement de l'étude (Réel)

1 février 2014

Dates d'inscription aux études

Première soumission

11 janvier 2014

Première soumission répondant aux critères de contrôle qualité

13 janvier 2014

Première publication (Estimation)

14 janvier 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 février 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NJFY13007
  • JQX12009 (Autre subvention/numéro de financement: Nanjing Municipal Bureau of Health)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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