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Completed

NCT Number: NCT02885350

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

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maternity Hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, FI-00610, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal analgesia for labour pain

Drug

Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique

Epidural analgesia for labour pain

Drug

Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.

Other names: labor epidural, labour epidural

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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