Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Sponsor

Women's Hospital HUS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094946

Collaborator

Helsinki University Central Hospital (Other)

100

Enrollment

Location

Anticipated Duration (Months)

49.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HUS/Women's hospital dept of anaesthesia	Helsinki		Finland	00029

Sponsors and Collaborators

Women's Hospital HUS
Helsinki University Central Hospital

Investigators

Study Director: Riina Jernman, MD PhD, Helsinki University Hospital Women's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antti Vaananen, Anesthesiologist MD PhD, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT06094946

Other Study ID Numbers:

PCEA_15102023

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antti Vaananen, Anesthesiologist MD PhD, Helsinki University Central Hospital

epidural analgesia

labour epidural

patient controlled epidural

Additional relevant MeSH terms:

Labor Pain

Fentanyl

Ropivacaine

Study Results

No Results Posted as of Oct 23, 2023