Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Not yet recruiting

• Conditions: Labor Pain
• Interventions: Drug: Ropivacaine Hydrocloride; Drug: Fentanyl Citrate

• Registration Number: NCT06094946
• Lead Sponsor: Women's Hospital HUS

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 Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Study Start: 2024-12
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midwife administered boluses	Ropivacaine Hydrocloride	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
Midwife administered boluses	Fentanyl Citrate	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
Automated and parturient controlled epidural boluses	Fentanyl Citrate	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.
Automated and parturient controlled epidural boluses	Ropivacaine Hydrocloride	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.

Primary Outcome Measures

Name	Time	Method
Parturient satisfaction with analgesia	During use of labour analgesia (up to 6 hours)	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)

Secondary Outcome Measures

Name	Time	Method
Midwife satisfaction with epidural labour analgesia	During use of labour analgesia (up to 6 hours)	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
Support person's satisfaction with epidural labour analgesia	During use of labour analgesia (up to 6 hours)	Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)

Trial Locations

Locations (1)

HUS/Women's hospital dept of anaesthesia; 🇫🇮 Helsinki, Finland