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Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Primary Purpose

Labor Pain

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Bupivacaine 0.08% - fentanyl 2mcg

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor analgesia, Programmed intermittent epidural bolus

Eligibility Criteria

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

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

Sites / Locations

BC Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min

Outcomes

Primary Outcome Measures

Breakthrough pain

Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain

Secondary Outcome Measures

Full Information

NCT ID

NCT03712735

First Posted

October 17, 2018

Last Updated

April 22, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03712735

Brief Title

Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 23, 2018 (Actual)

Primary Completion Date

March 2, 2021 (Actual)

Study Completion Date

March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Labor Pain

Keywords

Labor analgesia, Programmed intermittent epidural bolus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min

Arm Title

Group B

Arm Type

Experimental

Arm Description

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min

Arm Title

Group C

Arm Type

Experimental

Arm Description

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 0.08% - fentanyl 2mcg

Intervention Description

In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.

Primary Outcome Measure Information:

Title

Breakthrough pain

Description

Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain

Time Frame

Duration of labor with epidural

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anton Chau, MD MMSc

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

BC Women's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3N1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

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