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Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Primary Purpose

Labor Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Programmed intermittent epidural bolus
Continuous infusion
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant nulliparous or multiparous woman in labour
  • Age ≥18 years
  • Obtained consent for epidural analgesia
  • ASA classification I-II-III
  • Early labour (cervical dilation ≤6cm)

Exclusion Criteria:

  • Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
  • Prematurity (<36 weeks of gestation)
  • Multiple gestation
  • Fentanyl allergy or hypersensitivity
  • Patient unable to understand the PCEA
  • Fetal breech position
  • Maternal cardiac pathology and contraindication to Valsalva manoeuvre
  • Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
  • Intrathecal catheter or intravascular catheter
  • Accidental dural puncture
  • Patient refusal
  • Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia

Sites / Locations

  • CHUSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Study group

Arm Description

Continuous infusion + patient controlled epidural analgesia

Programmed intermittent epidural bolus + patient controlled analgesia

Outcomes

Primary Outcome Measures

Dose of bupivacaine in milligrams per hour
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours

Secondary Outcome Measures

Evaluation of pain
Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable
Anesthesiologist manual bolus
Total boluses by the anesthesiologist
PCEA boluses received
PCEA boluses received
PCEA boluses requested
PCEA boluses requested
Time lapse before the first PCEA request after the epidural connection
Time lapse before the first PCEA request after the epidural connection
First stage
Duration of the first stage of labour
Second stage
Duration of the second stage of labour
Assisted vaginal delivery
Number of assisted vaginal delivery (vacuum, forceps)
Cesarean section
Number of unplanned cesarean section
Motor blockade
Number of patients with a Bromage score ≥1
Patient satisfaction
Satisfaction of the analgesia provided by the epidural on a visual analog scale of 0-100, 0/100 being no satisfaction at all and 100/100 being entirely satisfied

Full Information

First Posted
October 27, 2018
Last Updated
May 22, 2022
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT03730753
Brief Title
Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia
Official Title
Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.
Detailed Description
Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Continuous infusion + patient controlled epidural analgesia
Arm Title
Study group
Arm Type
Experimental
Arm Description
Programmed intermittent epidural bolus + patient controlled analgesia
Intervention Type
Device
Intervention Name(s)
Programmed intermittent epidural bolus
Intervention Description
Programmed intermittent epidural bolus added to patient controlled epidural analgesia
Intervention Type
Device
Intervention Name(s)
Continuous infusion
Intervention Description
Continuous infusion added to patient controlled epidural analgesia
Primary Outcome Measure Information:
Title
Dose of bupivacaine in milligrams per hour
Description
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation of pain
Description
Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable
Time Frame
1 day
Title
Anesthesiologist manual bolus
Description
Total boluses by the anesthesiologist
Time Frame
1 day
Title
PCEA boluses received
Description
PCEA boluses received
Time Frame
1 day
Title
PCEA boluses requested
Description
PCEA boluses requested
Time Frame
1 day
Title
Time lapse before the first PCEA request after the epidural connection
Description
Time lapse before the first PCEA request after the epidural connection
Time Frame
1 day
Title
First stage
Description
Duration of the first stage of labour
Time Frame
1 day
Title
Second stage
Description
Duration of the second stage of labour
Time Frame
1 day
Title
Assisted vaginal delivery
Description
Number of assisted vaginal delivery (vacuum, forceps)
Time Frame
1 day
Title
Cesarean section
Description
Number of unplanned cesarean section
Time Frame
1 day
Title
Motor blockade
Description
Number of patients with a Bromage score ≥1
Time Frame
1 day
Title
Patient satisfaction
Description
Satisfaction of the analgesia provided by the epidural on a visual analog scale of 0-100, 0/100 being no satisfaction at all and 100/100 being entirely satisfied
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant nulliparous or multiparous woman in labour Age ≥18 years Obtained consent for epidural analgesia ASA classification I-II-III Early labour (cervical dilation ≤6cm) Exclusion Criteria: Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus) Prematurity (<36 weeks of gestation) Multiple gestation Fentanyl allergy or hypersensitivity Patient unable to understand the PCEA Fetal breech position Maternal cardiac pathology and contraindication to Valsalva manoeuvre Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus Intrathecal catheter or intravascular catheter Accidental dural puncture Patient refusal Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Caron, Dr.
Phone
+1 819 346-1110
Ext
5593
Email
isabelle.caron4@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève Rivard, Dr.
Phone
+1 819 346-1110
Ext
14403
Email
genevieve.rivard2@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Rivard, Dr.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genevieve Rivard, FRCPC
Phone
8195651502
Email
genevieve.rivard2@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Isabelle Caron
Email
isabelle.caron4@usherbrooke.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after publication for 5 years
IPD Sharing Access Criteria
All access requests and criteria will be reviewed by the investigators of this study.
Citations:
PubMed Identifier
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Citation
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Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

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