Labor PainPhase 4NCT02885350

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

A Phase 4 study testing Spinal analgesia for labour pain and Epidural analgesia for labour pain in people with Labor Pain, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Labor Pain
What is being tested?: Spinal analgesia for labour pain and Epidural analgesia for labour pain
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteFinland
Study dates: Sep 2016to May 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Maternity Hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, FI-00610

Other trials in Finland

About this study

Conditions: Labor Pain
Being tested: Spinal analgesia for labour pain, Epidural analgesia for labour pain
Medical subject headings: Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal analgesia for labour painDrug
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Epidural analgesia for labour painDrug
Also called labor epidural, labour epidural
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.

Study groups in NCT02885350
Study group	Role	What they receive
Spinal fentanyl	Active comparator	20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Epidural analgesia for labour pain

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 20 minutes

Secondary outcomes (1)

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.
Measured: The data below report an average duration of time that is typically less than three hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016May 2018

First posted31 Aug 2016 (estimated)
Study startSep 2016
Primary completionMay 2018
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Labor PainStudies of the same condition, open and under way.
More trials run by Helsinki University Central 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02885350
Sponsor's protocol ID: §12/19.6.2016/HUS/400/2016
Other IDs: 2016-000486-23, 2016
Status last verified: May 2021
First submitted: 26 Aug 2016
Last updated: 10 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 31286476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Labor Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
ClinicalTrials.gov ID: NCT02885350
Acronym / sponsor ID: §12/19.6.2016/HUS/400/2016
Conditions: Labor Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Helsinki University Central HospitalUniversity, hospital or other
Study start: Sep 2016
Primary completion: May 2018 (actual)
Study completion: May 2018 (actual)
First posted: 31 Aug 2016 (estimated)
Results: Posted 19 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Spinal fentanyl	Active comparator	Drug: Spinal analgesia for labour pain20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Epidural fentanyl	Experimental	Drug: Epidural analgesia for labour pain100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Spinal sufentanil	Active comparator	Drug: Spinal analgesia for labour pain5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Epidural sufentanil	Experimental	Drug: Epidural analgesia for labour pain20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

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
Spinal analgesia for labour painIntrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique	Drug	Spinal fentanyl, Spinal sufentanil
Epidural analgesia for labour painAlso: labor epidural, labour epiduralEpidural dose of either fentanyl or sufentanil delivered through an epidural catheter.	Drug	Epidural fentanyl, Epidural sufentanil

Primary outcome

Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
Time frame: 20 minutes
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.

1 secondary outcome

The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
Time frame: The data below report an average duration of time that is typically less than three hours

Results and safety

Results posted to the registry on 19 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Fentanyl	20	20
Epidural Fentanyl	20	20
Spinal Sufentanil	20	20
Epidural Sufentanil	20	20

Primary outcome: Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery

Time frame: 20 minutes. Mean (95% Confidence Interval). Unit: mm

Measure	Spinal Fentanyl n = 20	Epidural Fentanyl n = 20	Spinal Sufentanil n = 20	Epidural Sufentanil n = 20
Value	60 (46 to 74)	36 (24 to 47)	67 (54 to 81)	42 (30 to 55)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 minutes. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Fentanyl	0 of 20 (0%)	18 of 20 (90%)	0 of 20
Epidural Fentanyl	0 of 20 (0%)	8 of 20 (40%)	0 of 20
Spinal Sufentanil	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Epidural Sufentanil	0 of 20 (0%)	8 of 20 (40%)	0 of 20

Limitations and caveats (from the sponsor): No known limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31286476Vaananen 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.
Individual participant dataSharing planned: No

Related trials for Labor Pain

Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
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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.

Antti J Vaananen, M.D., Ph.D. principal investigator

Helsinki University Central Hospital (Katiloopiston sairaala)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Spinal analgesia for labour pain and Epidural analgesia for labour pain in people with Labor Pain, run by Helsinki University Central Hospital at 1 site in Finland.

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 4 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. 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. 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?

Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery (time frame: 20 minutes). 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 NCT02885350, 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 10 Jun 2021.