NCT00685672

Brief Summary

Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

2 active sites

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

May 21, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

7.4 years

First QC Date

May 21, 2008

Last Update Submit

March 29, 2016

Conditions

PregnancyPain

Keywords

labor analgesiafentanylepinephrine

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of fentanyl

    hours

Secondary Outcomes (1)

  • length of active labor

    hours

Study Arms (2)

1

EXPERIMENTAL

adrenalin

Drug: adrenalin

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

adrenalinDRUG

adrenalin 2 microgram pr ml placebo

1
placeboDRUG

Saline instead of adrenaline in the epidural mixture

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women at term in active labor

You may not qualify if:

  • age below 18 years
  • BMI \> 40
  • drug hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Lørenskog, Norway

Location

Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Related Publications (1)

  • Haidl F, Rosseland LA, Spigset O, Dahl V. Effects of Adrenaline on maternal and fetal fentanyl absorption in epidural analgesia: A randomized trial. Acta Anaesthesiol Scand. 2018 Oct;62(9):1267-1273. doi: 10.1111/aas.13175. Epub 2018 Jun 25.

    PMID: 29943508DERIVED

MeSH Terms

Conditions

Pain

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Vegard Dahl, PhD MD

    Dep of Anesethesiology, Akershus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 28, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

NO(2)