Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Ropivacaine Hydrocloride
* Drug: Fentanyl Citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Midwife administered boluses<br>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<br>* 1 mg/ml<br>Drug: Fentanyl Citrate<br>* 2.5 micrograms/ml<br>|
| Automated and parturient controlled epidural boluses<br>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<br>* 1 mg/ml<br>Drug: Fentanyl Citrate<br>* 2.5 micrograms/ml<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, labour epidural, patient controlled epidural