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

Phase 4

Completed

• Conditions: Labor Pain
• Interventions: Drug: Spinal analgesia for labour pain; Drug: Epidural analgesia for labour pain

• Registration Number: NCT02885350
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Study Start: 2016-09
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Results First Submitted: 2021-03-31
• Results First Submitted QC: 2021-04-28
• Status Verified: 2021-05
• Results First Posted: 2021-05-19
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal sufentanil	Spinal analgesia for labour pain	5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Epidural fentanyl	Epidural analgesia for labour pain	100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Spinal fentanyl	Spinal analgesia for labour pain	20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Epidural sufentanil	Epidural analgesia for labour pain	20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.

Primary Outcome Measures

Name	Time	Method
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery	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 Outcome Measures

Name	Time	Method
The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid	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.

Trial Locations

Locations (1)

Maternity Hospital, Helsinki University Central Hospital; 🇫🇮 Helsinki, Uusimaa, Finland