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Epidural Analgesia During Labour (PIEBvsPCEA)

Primary Purpose

Anesthesia, Obstetrical, Analgesia, Epidural

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
PIEB: Patient Intermittent Epidural Boluses
PCEA: Patient Controlled Epidural Analgesia
Sponsored by
Hospital del Río Hortega
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Obstetrical focused on measuring PIEB, PCEA, LEVOBUPIVACAINE

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 20- 40 years-old women
  • Primiparous women
  • Dilatation 3- 7 cm
  • No risk illnesses for epidural block
  • No risk pregnancy
  • Signed informed consent

Exclusion Criteria:

  • Illnesses which are a risk for pregnancy
  • Multiparous women
  • Contraindicated diseases for epidural block
  • Women who can not understand the procedure
  • Women who do not want to sign the informed consent
  • Patients with drug´s allergy

Sites / Locations

  • Hospital Universitario Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PIEB (Patient Intermittent Epidural Bolus)

PCEA (Patient continuous Epidural Analgesia)

Arm Description

PIEB: The boluses are programmed every 30 minutes. The patient can ask for another extra bolus in between if she wishes. The dosis per hour are equivalent to the PCEA. We make a comparison between PCEA vs PIEB.

PCEA: There is a continuous infusion and the patient can order extra boluses every 15 minutes. The dosis per hour are equivalent to the other arm to the PIEB. We make a comparison between PCEA vs PIEB.

Outcomes

Primary Outcome Measures

VAS
Change from baseline in Visual Analog Scale

Secondary Outcome Measures

Satisfaction (Likert Scale)
1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)
Bromage Scale
Labour Outcome
Eutocic
Labour Outcome
instrumental
Labour Outcome
cesarean section
Expulsive time
Apgar at birth
Apgar measured in 1 minute
Apgar at birth
Apgar measured in 5 minutes
fetal pH at birth
0 minutes after delivery
Total Dosis of Levobupivacaine
miligrams

Full Information

First Posted
September 12, 2016
Last Updated
August 2, 2018
Sponsor
Hospital del Río Hortega
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1. Study Identification

Unique Protocol Identification Number
NCT03133091
Brief Title
Epidural Analgesia During Labour
Acronym
PIEBvsPCEA
Official Title
Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Río Hortega

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.
Detailed Description
There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Obstetrical, Analgesia, Epidural
Keywords
PIEB, PCEA, LEVOBUPIVACAINE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIEB (Patient Intermittent Epidural Bolus)
Arm Type
Active Comparator
Arm Description
PIEB: The boluses are programmed every 30 minutes. The patient can ask for another extra bolus in between if she wishes. The dosis per hour are equivalent to the PCEA. We make a comparison between PCEA vs PIEB.
Arm Title
PCEA (Patient continuous Epidural Analgesia)
Arm Type
Active Comparator
Arm Description
PCEA: There is a continuous infusion and the patient can order extra boluses every 15 minutes. The dosis per hour are equivalent to the other arm to the PIEB. We make a comparison between PCEA vs PIEB.
Intervention Type
Drug
Intervention Name(s)
PIEB: Patient Intermittent Epidural Boluses
Intervention Description
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
Intervention Type
Drug
Intervention Name(s)
PCEA: Patient Controlled Epidural Analgesia
Intervention Description
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
Primary Outcome Measure Information:
Title
VAS
Description
Change from baseline in Visual Analog Scale
Time Frame
4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery
Secondary Outcome Measure Information:
Title
Satisfaction (Likert Scale)
Description
1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)
Time Frame
1 hour after delivery
Title
Bromage Scale
Time Frame
15 minutes after Epidural Block and 1 hour after epidural block
Title
Labour Outcome
Description
Eutocic
Time Frame
Delivery
Title
Labour Outcome
Description
instrumental
Time Frame
Delivery
Title
Labour Outcome
Description
cesarean section
Time Frame
Delivery
Title
Expulsive time
Time Frame
From 10 cm of dilatation until delivery
Title
Apgar at birth
Description
Apgar measured in 1 minute
Time Frame
1 minute after birth
Title
Apgar at birth
Description
Apgar measured in 5 minutes
Time Frame
5 minutes after birth
Title
fetal pH at birth
Description
0 minutes after delivery
Time Frame
0 minutes after delivery
Title
Total Dosis of Levobupivacaine
Description
miligrams
Time Frame
0 minutes after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20- 40 years-old women Primiparous women Dilatation 3- 7 cm No risk illnesses for epidural block No risk pregnancy Signed informed consent Exclusion Criteria: Illnesses which are a risk for pregnancy Multiparous women Contraindicated diseases for epidural block Women who can not understand the procedure Women who do not want to sign the informed consent Patients with drug´s allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M BELEN RODRIGUEZ-CAMPOO
Organizational Affiliation
Resident
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23223119
Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
15197122
Citation
Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.
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Citation
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Citation
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Citation
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Results Reference
derived

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Epidural Analgesia During Labour

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