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Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

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ClinicalTrials.gov Identifier: NCT03712735
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Anton Chau, University of British Columbia

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

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Bupivacaine 0.08% - fentanyl 2mcg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:

PIEB flow rate = high; interval = 60 min

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.

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

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712735


Contacts
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Contact: James D Taylor, BSc 604-875-2424 ext 6076 james.taylor1@phsa.ca
Contact: Kelly Au, BSc MD 604-875-2424 ext 6076 kelly.au@cw.bc.ca

Locations
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Canada, British Columbia
BC Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: James D Taylor, BSc    604-875-2424 ext 6076    james.taylor1@phsa.ca   
Contact: Kelly Au, BSc MD    604-875-2424 ext 6076    kelly.au@cw.bc.ca   
Principal Investigator: Anton Chau, MD MMSc         
Sub-Investigator: Kelly Au, MD         
Sub-Investigator: Zahid Sunderani, MD         
Sub-Investigator: James Taylor, BSc         
Sub-Investigator: Arianne Albert, PhD         
Sub-Investigator: Simon Massey, MB BCh FRCPC         
Sub-Investigator: Roanne Preston, MD FRCPC         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Anton Chau, MD MMSc University of British Columbia

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Responsible Party: Anton Chau, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03712735     History of Changes
Other Study ID Numbers: H18-02318
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anton Chau, University of British Columbia:
Labor analgesia
Programmed intermittent epidural bolus

Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General