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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005506-26 | EudraCT Number |
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A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).
They will be monitored for the development of analgesia for a duration of 30 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal fentanyl | Active Comparator | Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace. An epidural catheter is left in place for subsequent analgesic doses. |
|
| Epidural lidocaine and fentanyl | Experimental | Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Citrate | Drug | Fentanyl citrate 20 µg in 2 ml of saline injected into csf |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia at 20 minutes | Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value. 0 mm means no pain while 100 mm means worst possible pain. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time until pain returns to 60 mm VAS | Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale | 30-180 minutes |
| Ambulation during the analgesia provided by the intervention |
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Inclusion Criteria:
Exclusion Criteria:
All recruited patients are parturients undergoing induction of labor
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| Name | Affiliation | Role |
|---|---|---|
| Antti J Vaananen, MD PhD | HUCH, Women's hospital/dept of anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS/Women's hospital dept of anaesthesia | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38366324 | Background | Salmi L, Jernman R, Vaananen A. Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour? Acta Anaesthesiol Scand. 2024 May;68(5):664-674. doi: 10.1111/aas.14389. Epub 2024 Feb 16. |
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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 |
|---|---|
| D005283 | Fentanyl |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
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60 parturients randomized to two different treatment arms (30 in each group)
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The parturient and the midwife as well as the researcher doing the interview for analgesia will be masked. The anesthesiologist performing either spinal fentanyl administration or epidural analgesia will not be masked
| Lidocaine 1% Injectable Solution |
| Drug |
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume |
|
| Fentanyl Citrate | Drug | Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume |
|
HAs the parturient been walking during the analgesia provided by the intervention
| 30-180 minutes |
| Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention | Graded as normal, susceptible, pathological | 0-30 minutes |
| Pruritus | The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable | 0-30 minutes |
| SAtisfaction of the parturient with the analgesia provided by the intervention | On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction. | at 30 minutes |
| Cervical dilatation rate cm/h during the analgesia intervention | (The cervical dilatation (1-10 cm) 1-3 hours post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (hours) | 0-180 min |
| Use of oxytocin during the analgesia study period | Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no) | 30 min |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |