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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03712735
Enrollment
390
Registered
2018-10-19
Start date
2018-10-23
Completion date
2021-03-02
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Labor analgesia, Programmed intermittent epidural bolus

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.

Interventions

DRUGBupivacaine 0.08% - fentanyl 2mcg

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

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Breakthrough painDuration of labor with epiduralProportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026