Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

November 28, 2023 updated by: Geneviève Rivard, Université de Sherbrooke

Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Continuous infusion + patient controlled epidural analgesia
Device: Continuous infusion
Continuous infusion added to patient controlled epidural analgesia
Experimental: Study group
Programmed intermittent epidural bolus + patient controlled analgesia
Device: Programmed intermittent epidural bolus
Programmed intermittent epidural bolus added to patient controlled epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of bupivacaine in milligrams per hour
Time Frame: 1 day
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Geneviève Rivard, Dr., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018 - 2686

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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