Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
1 other identifier
interventional
390
1 country
1
Brief Summary
Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2021
CompletedApril 26, 2021
April 1, 2021
2.4 years
October 17, 2018
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breakthrough pain
Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain
Duration of labor with epidural
Study Arms (3)
Group A
ACTIVE COMPARATORBupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min
Group B
EXPERIMENTALBupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min
Group C
EXPERIMENTALBupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min
Interventions
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Chau, MD MMSc
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
October 17, 2018
First Posted
October 19, 2018
Study Start
October 23, 2018
Primary Completion
March 2, 2021
Study Completion
March 2, 2021
Last Updated
April 26, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share