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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Spinal analgesia for labour pain; Drug: Epidural analgesia for labour pain

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, FI-00610
      • Maternity Hospital, Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal fentanyl; 20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.	Drug: Spinal analgesia for labour pain; Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Experimental: Epidural fentanyl; 100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.	Drug: Epidural analgesia for labour pain; Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.; Other Names: labor epidural; labour epidural
Active Comparator: Spinal sufentanil; 5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.	Drug: Spinal analgesia for labour pain; Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Experimental: Epidural sufentanil; 20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.	Drug: Epidural analgesia for labour pain; Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.; Other Names: labor epidural; labour epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Antti J Vaananen, M.D., Ph.D., Helsinki University Central Hospital (Katiloopiston sairaala)

Publications and helpful links

General Publications

• Vaananen A, Kuukasjarvi 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: §12/19.6.2016/HUS/400/2016; 2016-000486-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No