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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04645823
Other study ID # Versio4_22112020
Secondary ID 2020-005506-26
Status Completed
Phase Phase 4
First received
Last updated
Start date March 26, 2021
Est. completion date May 19, 2023

Study information

Verified date April 2024
Source Women's Hospital HUS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 19, 2023
Est. primary completion date May 19, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Signs a consent form to participate voluntarily into the trial 2. Induced labor 3. singleton pregnancy 4. primiparous 5. BMI 20-40 at the time of delivery 6. No history of allergy for lidocaine or fentanyl 7. sufficient command of Finnish language to understand the consent form and interview 8. Cervical dilatation at maximum 4 cm at the time of intervention Exclusion Criteria: 1. Any contraindication for spinal or epidural analgesia 2. Allergy for lidocaine or fentanyl 3. The patient has received any opioid medication within 90 minutes prior to intervention

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fentanyl Citrate
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Lidocaine 1% Injectable Solution
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Fentanyl Citrate
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume

Locations

Country Name City State
Finland HUS/Women's hospital dept of anaesthesia Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Women's Hospital HUS

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Ambulation during the analgesia provided by the intervention HAs the parturient been walking during the analgesia provided by the intervention 30-180 minutes
Secondary Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention Graded as normal, susceptible, pathological 0-30 minutes
Secondary Pruritus The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable 0-30 minutes
Secondary 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
Secondary 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
Secondary Use of oxytocin during the analgesia study period Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no) 30 min
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