Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl
A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics to prolong the duration of analgesia and improve the analgesic effect. However, dose combinations of local anesthetics and opioids, especially in the initial loading dose, vary greatly from hospital to hospital and often depend upon the different routines adopted by anesthesiologists. In clinical practice, there are still some controversy about opioid dose selection in terms of analgesic onset time and adverse reactions.
In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in the clinic, and extended the observation period to 24 hours after delivery. We hypothesized that increasing the concentration of local anesthetic, rather than increasing the dose of sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the mother and fetus. To test our hypothesis, our primary outcome was to compare the times of analgesia onset of the three combinations, and the secondary outcomes were to compare the effects on maternal and infant adverse reactions.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Shanghai, Chine
- Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:patients ASA physical status 1 or 2; early labour (cervical dilation 5 cm or less); singleton fetus; gestational age > 36 weeks; and normal fetal heart rate (FHR) tracing. -
Exclusion Criteria:severe preeclampsia;antepartum haemorrhage; ASA 3 or more; chronic pain; substance abuse;contraindications to epidural analgesia; allergies to local anaesthetics or fentanyl; body mass index (BMI) over 40; and previous administration of opioid analgesia within 24 h.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 0.1%bupivacaine+10µg sufentanyl
Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose.
After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
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Women were then placed supine with left uterine displacement.
Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose.
After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
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Comparateur actif: 0.125%bupivacaine+5µg sufentanyl
Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose.
After 3 min, 10 ml of 0.125% bupivacaine epidural was injected
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Women were then placed supine with left uterine displacement.
Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose.
After 3 min, 10 ml of 0.125% bupivacaine epidural was injected
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Comparateur actif: 0.1%bupivacaine+5µg sufentanyl
Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose.
After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
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Women were then placed supine with left uterine displacement.
Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose.
After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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the time to achieve effective analgesia
Délai: 30 min
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We defined the onset of analgesia as the time from the start of the injection to the time when the NPRS score was reduced to at least half of the original score.
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30 min
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Sensory block, maternal side effects (pruritus, hypotension, sedation，motor block and decreased fetal heart rate) were recorded at 5-min intervals for 30 min. sedation)
Délai: 30min
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30min
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time from the first PCA bolus, patient satisfaction, type of delivery, fever, establishment of breast feeding and LATCH score within 24 h, cumulative dosage of sufentanil/bupivacaine, time from bolus to delivery.
Délai: delivery 24h
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delivery 24h
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Shaoqiang Huang, PhD, Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TWang20171226
Informations sur les médicaments et les dispositifs, documents d'étude
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