Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
NCT ID: NCT02885350
Last Updated: 2021-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2016-09-30
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Spinal fentanyl
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Epidural fentanyl
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Spinal sufentanil
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Epidural sufentanil
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Interventions
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Spinal analgesia for labour pain
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Epidural analgesia for labour pain
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Contraindications for epidural/spinal analgesia
* BMI at the time of delivery under 20 or over 35 kg/m2
18 Years
45 Years
FEMALE
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Jouni Ahonen
MD, Ph.D.
Principal Investigators
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Antti J Vaananen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital (Katiloopiston sairaala)
Locations
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Maternity Hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-000486-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
§12/19.6.2016/HUS/400/2016
Identifier Type: -
Identifier Source: org_study_id
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