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Clinical Trials/NCT03712735
NCT03712735
Completed
Phase 4

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

University of British Columbia1 site in 1 country390 target enrollmentOctober 23, 2018

Overview

Phase
Phase 4
Intervention
Bupivacaine 0.08% - fentanyl 2mcg
Conditions
Labor Pain
Sponsor
University of British Columbia
Enrollment
390
Locations
1
Primary Endpoint
Breakthrough pain
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2018
End Date
March 2, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony Chau

Clinical Assistant Professor

University of British Columbia

Eligibility Criteria

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

Arms & Interventions

Group A

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min

Intervention: Bupivacaine 0.08% - fentanyl 2mcg

Group B

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min

Intervention: Bupivacaine 0.08% - fentanyl 2mcg

Group C

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min

Intervention: Bupivacaine 0.08% - fentanyl 2mcg

Outcomes

Primary Outcomes

Breakthrough pain

Time Frame: Duration of labor with epidural

Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain

Study Sites (1)

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