Safety of Epidural Fentanyl and Adrenalin During Childbirth

NCT ID: NCT00685672

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

adrenalin

Group Type EXPERIMENTAL

adrenalin

Intervention Type DRUG

adrenalin 2 microgram pr ml placebo

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Saline instead of adrenaline in the epidural mixture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adrenalin

adrenalin 2 microgram pr ml placebo

Intervention Type DRUG

placebo

Saline instead of adrenaline in the epidural mixture

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women at term in active labor

Exclusion Criteria

* age below 18 years
* BMI \> 40
* drug hypersensitivity
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leiv Arne Rosseland

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vegard Dahl, PhD MD

Role: STUDY_DIRECTOR

Dep of Anesethesiology, Akershus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Akershus University Hospital

Lørenskog, , Norway

Site Status

Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29943508 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUDRACT 2007-000322-52

Identifier Type: -

Identifier Source: secondary_id

edaadr-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.