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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885350
• Other study ID #: §12/19.6.2016/HUS/400/2016
• Secondary ID: 2016-000486-23
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Finland	Maternity Hospital, Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Väänänen A, Kuukasjärvi M, Tekay A, Ahonen J. Spinal and epidural sufentanil and fentanyl in early labour. Acta Anaesthesiol Scand. 2019 Nov;63(10):1413-1418. doi: 10.1111/aas.13450. Epub 2019 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery	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.	20 minutes
Secondary	The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid	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.	The data below report an average duration of time that is typically less than three hours