NCT02885350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

August 26, 2016

Results QC Date

March 31, 2021

Last Update Submit

May 27, 2021

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

Spinal fentanyl

ACTIVE COMPARATOR

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

Drug: Spinal analgesia for labour pain

Epidural fentanyl

EXPERIMENTAL

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

Drug: Epidural analgesia for labour pain

Spinal sufentanil

ACTIVE COMPARATOR

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

Drug: Spinal analgesia for labour pain

Epidural sufentanil

EXPERIMENTAL

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

Drug: Epidural analgesia for labour pain

Interventions

Spinal analgesia for labour painDRUG

Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique

Spinal fentanylSpinal sufentanil
Epidural analgesia for labour painDRUG

Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.

Also known as: labor epidural, labour epidural
Epidural fentanylEpidural sufentanil

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, FI-00610, Finland

Location

Related Publications (1)

  • 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.

    PMID: 31286476RESULT

MeSH Terms

Conditions

Labor Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Limitations and Caveats

No known limitations.

Results Point of Contact

Title
Dr Antti Vaananen
Organization
Helsinki University Central hospital/Women's hospital/anaesthesia
antti.vaananen@hus.fi
358504271850

Study Officials

  • Antti J Vaananen, M.D., Ph.D.

    Helsinki University Central Hospital (Katiloopiston sairaala)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 10, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)