Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Phase 4

Completed

• Conditions: Labor Pain
• Interventions: Drug: Bupivacaine 0.08% - fentanyl 2mcg

• Registration Number: NCT03712735
• Lead Sponsor: University of British Columbia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2018-10-23
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 390

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Bupivacaine 0.08% - fentanyl 2mcg	Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min
Group A	Bupivacaine 0.08% - fentanyl 2mcg	Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min
Group B	Bupivacaine 0.08% - fentanyl 2mcg	Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min

Primary Outcome Measures

Name	Time	Method
Breakthrough pain	Duration of labor with epidural	Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada