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NCT03712735 Clinical Trial

Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03712735
Other study ID # H18-02318
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 23, 2018
Est. completion date March 2, 2021

Study information
Verified date April 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date March 2, 2021
Est. primary completion date March 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada BC Women's Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Breakthrough pain Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain Duration of labor with epidural
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Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
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Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
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