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

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Spinal analgesia for labour pain
Epidural analgesia for labour pain
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maternity Hospital, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Spinal fentanyl

Epidural fentanyl

Spinal sufentanil

Epidural sufentanil

Arm Description

20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.

100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.

5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.

20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 26, 2016
Last Updated
May 27, 2021
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02885350
Brief Title
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Official Title
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal fentanyl
Arm Type
Active Comparator
Arm Description
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Arm Title
Epidural fentanyl
Arm Type
Experimental
Arm Description
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Arm Title
Spinal sufentanil
Arm Type
Active Comparator
Arm Description
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Arm Title
Epidural sufentanil
Arm Type
Experimental
Arm Description
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Intervention Type
Drug
Intervention Name(s)
Spinal analgesia for labour pain
Intervention Description
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Intervention Type
Drug
Intervention Name(s)
Epidural analgesia for labour pain
Other Intervention Name(s)
labor epidural, labour epidural
Intervention Description
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Primary Outcome Measure Information:
Title
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
Description
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.
Time Frame
The data below report an average duration of time that is typically less than three hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti J Vaananen, M.D., Ph.D.
Organizational Affiliation
Helsinki University Central Hospital (Katiloopiston sairaala)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
FI-00610
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31286476
Citation
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.
Results Reference
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Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

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