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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Shanghai, China
- Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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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Aktiver Komparator: 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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Aktiver Komparator: 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
|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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the time to achieve effective analgesia
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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)
Zeitfenster: 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.
Zeitfenster: delivery 24h
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delivery 24h
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Shaoqiang Huang, PhD, Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TWang20171226
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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