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Completed

NCT Number: NCT03712735

Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

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

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.08% - fentanyl 2mcg

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2018
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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