Skip to main content
Clinical Trials/NCT06094946
NCT06094946
Not yet recruiting
Not Applicable

Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump

Women's Hospital HUS1 site in 1 country100 target enrollmentStarted: December 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Women's Hospital HUS
Enrollment
100
Locations
1
Primary Endpoint
Parturient satisfaction with analgesia

Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Midwife administered boluses

The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued on-demand by similar boluses until delivery

Intervention: Ropivacaine Hydrocloride (Drug)

Midwife administered boluses

The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued on-demand by similar boluses until delivery

Intervention: Fentanyl Citrate (Drug)

Automated and parturient controlled epidural boluses

The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued by automated boluses of the same solution (6ml every 40 minutes) with possibility for the parturient to administer 6 ml extra doses with a 20 minute lock-out. Maximum hourly dose 20 ml.

Intervention: Ropivacaine Hydrocloride (Drug)

Automated and parturient controlled epidural boluses

The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued by automated boluses of the same solution (6ml every 40 minutes) with possibility for the parturient to administer 6 ml extra doses with a 20 minute lock-out. Maximum hourly dose 20 ml.

Intervention: Fentanyl Citrate (Drug)

Outcomes

Primary Outcomes

Parturient satisfaction with analgesia

Time Frame: During use of labour analgesia (up to 6 hours)

Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)

Secondary Outcomes

  • Midwife satisfaction with epidural labour analgesia(During use of labour analgesia (up to 6 hours))
  • Support person's satisfaction with epidural labour analgesia(During use of labour analgesia (up to 6 hours))

Investigators

Sponsor
Women's Hospital HUS
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antti Vaananen

Anesthesiologist MD PhD

Helsinki University Central Hospital

Study Sites (1)

Loading locations...

Similar Trials