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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Labor Pain

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