PregnancyPhase 4NCT00685672
Safety of Epidural Fentanyl and Adrenalin During Childbirth
A Phase 4 study testing adrenalin in people with Pregnancy and Pain, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- What is being tested?
- adrenalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2008to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women at term in active labor
Who cannot join
- age below 18 years
- BMI > 40
- drug hypersensitivity
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital
Oslo, 0027
About this study
Official title: Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth
Read the detailed description
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.
- Being tested
- adrenalin, placebo
- Keywords
- labor analgesia, fentanyl, epinephrine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenalinDrug
adrenalin 2 microgram pr ml placebo
placeboDrug
Saline instead of adrenaline in the epidural mixture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | adrenalin Receives: Drug: adrenalin |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of fentanyl
Measured: hours
Secondary outcomes (1)
length of active labor
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
- Investigators
- Vegard Dahl, PhD MD, Study director, Dep of Anesethesiology, Akershus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685672
- Sponsor's protocol ID
- edaadr-07
- Other IDs
- EUDRACT 2007-000322-52
- Status last verified
- Mar 2016
- First submitted
- 21 May 2008
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29943508
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
- ClinicalTrials.gov ID
- NCT00685672
- Acronym / sponsor ID
- edaadr-07
- Keywords
- labor analgesia, fentanyl, epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- Aug 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: adrenalinadrenalin |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women at term in active labor
Key exclusion criteria (3 listed)
- age below 18 years
- BMI > 40
- drug hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adrenalinadrenalin 2 microgram pr ml placebo | Drug | 1 |
| placeboSaline instead of adrenaline in the epidural mixture | Drug | 2 |
Primary outcome
Plasma concentration of fentanyl
Time frame: hours
1 secondary outcome
length of active labor
Time frame: hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Derived from this study: PubMed 29943508Haidl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Dahl, PhD MD study director
Dep of Anesethesiology, Akershus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adrenalin in people with Pregnancy and Pain, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of fentanyl (time frame: hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00685672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.