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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000486-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal fentanyl | Active Comparator | 20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml. |
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| Epidural fentanyl | Experimental | 100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml. |
|
| Spinal sufentanil | Active Comparator | 5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml. |
|
| Epidural sufentanil | Experimental | 20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal analgesia for labour pain | Drug | Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The data below report an average duration of time that is typically less than three hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antti J Vaananen, M.D., Ph.D. | Helsinki University Central Hospital (Katiloopiston sairaala) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Hospital, Helsinki University Central Hospital | Helsinki | Uusimaa | FI-00610 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31286476 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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 |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Parturients in active labour
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Epidural Fentanyl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mm | 20 minutes |
|
30 minutes
The parturient is monitored for 30 minutes after the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | Opioid induced pruritus |
No known limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Antti Vaananen | Helsinki University Central hospital/Women's hospital/anaesthesia | 358504271850 | antti.vaananen@hus.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2016 | May 27, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Epidural analgesia for labour pain | Drug | Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter. |
|
|
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. |
| BG002 | 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 |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain visual analog scale at 0-100 mm | A 100 mm visual analog scale (VAS) is used, where 0 mm presents no pain at all and 100 mm presents the worst possible pain. | Mean | Standard Deviation | mm |
|
| 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. |
| OG002 | 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 |
| OG003 | 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. |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | min | The data below report an average duration of time that is typically less than three hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 18 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | 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 | 0 | 20 | 0 | 20 | 12 | 20 |
| EG003 | 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. | 0 | 20 | 0 | 20 | 8 | 20 |
|
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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