Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Overview

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

Full Title of Study: “Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Group A
    • Bupivacaine 0.08% – fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min
  • Experimental: Group B
    • Bupivacaine 0.08% – fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min
  • Experimental: Group C
    • Bupivacaine 0.08% – fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anton Chau, Clinical Assistant Professor – University of British Columbia
  • Overall Official(s)
    • Anton Chau, MD MMSc, Principal Investigator, University of British Columbia
  • Overall Contact(s)
    • James D Taylor, BSc, 604-875-2424, james.taylor1@phsa.ca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.