Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

Overview

In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2018

Interventions

  • Drug: Spinal analgesia for labour pain
    • Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
  • Drug: Epidural analgesia for labour pain
    • Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.

Arms, Groups and Cohorts

  • Active Comparator: Spinal fentanyl
    • 20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
  • Experimental: Epidural fentanyl
    • 100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
  • Active Comparator: Spinal sufentanil
    • 5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
  • Experimental: Epidural sufentanil
    • 20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.

Clinical Trial Outcome Measures

Primary Measures

  • Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
    • Time Frame: 20 minutes
    • All parturients are to have a pain visual analog scale (VAS – on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.

Secondary Measures

  • The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
    • Time Frame: The data below report an average duration of time that is typically less than three hours
    • The time from the study drug dose to the administration of next epidural bolus, up to five hours. After the study drug dose all parturients wil have epidural catheters in place for subsequent analgesia.

Participating in This Clinical Trial

Inclusion Criteria

  • Primiparous parturients – In early phase of labour (cervical dilatation at or under 5 cm) – No prior opioids by any route of administration within past 120 min – Pain at or over 80 mm on 0-100 mm visual analog scale during contraction Exclusion Criteria:

  • Allergy for any of the medications used – Contraindications for epidural/spinal analgesia – BMI at the time of delivery under 20 or over 35 kg/m2

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jouni Ahonen, MD, Ph.D. – Helsinki University Central Hospital
  • Overall Official(s)
    • Antti J Vaananen, M.D., Ph.D., Principal Investigator, Helsinki University Central Hospital (Katiloopiston sairaala)

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