Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

Labor Pain Clinical Trial

Official title:

Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

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
• 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
• 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

Related Conditions & MeSH terms

• Induced; Birth
• Labor Pain

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