Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Ropivacaine Hydrocloride; Drug: Fentanyl Citrate

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Antti J Vaananen, MD PhD; Phone Number: +358504271850; Email: antti.vaananen@hus.fi
• Study Contact Backup: Name: Riina Jernman, MD PhD; Phone Number: +358504272584; Email: riina.jernman@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • HUS/Women's hospital dept of anaesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Parturients coming to the delivery hospital (a tertiary delivery hospital with 8000 deliveries per year and 85 % epidural rate) for intended vaginal delivery and requesting epidural analgesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Ropivacaine Hydrocloride; 1 mg/ml; Drug: Fentanyl Citrate; 2.5 micrograms/ml
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.	Drug: Ropivacaine Hydrocloride; 1 mg/ml; Drug: Fentanyl Citrate; 2.5 micrograms/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Women's Hospital HUS
• Collaborators: Helsinki University Central Hospital
• Investigators: Study Director: Riina Jernman, MD PhD, Helsinki University Hospital Women's hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: epidural analgesia; labour epidural; patient controlled epidural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: PCEA_15102023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymous data upon reasonable request with accepted study plan from an academic institution can be shared based on case-by-case assessment by the researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No