Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Labor Pain Clinical Trial

Official title:

Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094946
• Other study ID #: PCEA_15102023
• Status: Not yet recruiting
• Start date: December 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Women's Hospital HUS
• Contact: Antti J Vaananen, MD PhD
• Phone: +358504271850
• Email: antti.vaananen[@]hus.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Those prospective parturients that express that they may want an epidural labour analgesia for their delivery will be informed about the possibility to choose between a pump driven epidural or midwife administered intermittent boluses.

Description:

The purpose is to compare parturient and midwife satisfaction with the epidural labour analgesia when epidural analgesia is maintained by an epidural bolus pump (automated mandatory boluses with patient controlled boluses without background infusion) or midwife administered on-demand boluses.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 18 years or older
• Admitted to the delivery hospital with the prospect of vaginal delivery
• On admission when questioned about planned analgesia expresses that may want an epidural analgesia for the planned vaginal delivery
• After reading the study prochure signs the participation (consent) form
• Sufficient command of Finnish or Swedish to facilitate interview

Exclusion Criteria:

• Contraindications for epidural analgesia
• Planned cesarean delivery
• Age under 18 years

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Ropivacaine Hydrocloride
1 mg/ml
• Fentanyl Citrate
2.5 micrograms/ml

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Women's Hospital HUS	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parturient satisfaction with analgesia	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)	During use of labour analgesia (up to 6 hours)
Secondary	Midwife satisfaction with epidural labour analgesia	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)	During use of labour analgesia (up to 6 hours)
Secondary	Support person's satisfaction with epidural labour analgesia	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)	During use of labour analgesia (up to 6 hours)