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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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