Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

April 22, 2021 updated by: Anthony Chau, University of British Columbia

Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial

Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton, vertex presentations at term (37-42 weeks gestational age)
  • </= 5cm cervical dilation at the time of epidural anesthesia request
  • ASA 2-3 patients aged 19 or over who are able to provide informed consent

Exclusion Criteria:

  • Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
  • History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
  • Current or historical evidence of any significant medical conditions
  • Clinical settings in which continuous epidural infusion may be preferable
  • Risk factors significantly increasing the need for Cesarean delivery
  • Anticipated fetal abnormalities

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:

PIEB flow rate = high; interval = 60 min
Drug: Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Experimental: Group B
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min
Drug: Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Experimental: Group C
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min
Drug: Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breakthrough pain
Time Frame: Duration of labor with epidural
Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain
Duration of labor with epidural

Collaborators and Investigators

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

Sponsor

University of British Columbia

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)

October 23, 2018

Primary Completion (Actual)

March 2, 2021

Study Completion (Actual)

March 2, 2021

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18-02318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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