Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871530
Recruitment Status : Unknown
Verified June 2019 by Allana, IWK Health Centre.
Recruitment status was:  Recruiting
First Posted : March 12, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Allana, IWK Health Centre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.

Condition or disease Intervention/treatment Phase
Labor Pain Other: Coordinate A Other: Coordinate B Other: Coordinate C Other: Coordinate D Other: Coordinate E Other: Coordinate F Other: Coordinate G Other: Coordinate H Other: Coordinate I Other: Coordinate J Other: Coordinate K Other: Coordinate L Other: Coordinate M Other: Coordinate N Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Coordinate A
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
 Other: Coordinate A
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Experimental: Coordinate B
PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate B
PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Experimental: Coordinate C
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
 Other: Coordinate C
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Experimental: Coordinate D
PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate D
PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Experimental: Coordinate E
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
 Other: Coordinate E
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
Experimental: Coordinate F
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
 Other: Coordinate F
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
Experimental: Coordinate G
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
 Other: Coordinate G
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
Experimental: Coordinate H
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
 Other: Coordinate H
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
Experimental: Coordinate I
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
 Other: Coordinate I
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Experimental: Coordinate J
PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate J
PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Experimental: Coordinate K
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
 Other: Coordinate K
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Experimental: Coordinate L
PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate L
PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Experimental: Coordinate M
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate M
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Experimental: Coordinate N
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
 Other: Coordinate N
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maternal satisfaction score [ Time Frame: 24 hours following delivery ]
    quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied

  2. Number of clinician administered rescue boluses [ Time Frame: Start of labour epidural to delivery time ]
    Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump

  3. Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered [ Time Frame: Start of labour epidural to delivery time ]
    Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nulliparous,
  • English speaking
  • 18-45 years
  • single gestation ≥ 37 weeks
  • vertex presentation
  • American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
  • requesting an epidural for labour analgesia
  • cervical dilation ≤ 7 cm at the time of initiation of epidural analgesia.

Exclusion Criteria:

  • Preeclampsia or HELLP syndrome
  • maternal cardiac disease
  • severe or uncontrolled maternal systemic disease
  • contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
  • abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
  • chronic analgesic use
  • a physical or psychiatric condition which may impair cooperation
  • known fetal anomalies/intrauterine fetal demise
  • height < 5'0"
  • Body Mass Index > 45 kg/m2
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03871530


Contacts
Layout table for location contacts
Contact: Joanne Street 902-470-7879 joanne.street@iwk.nshealth.ca
Contact: Lorraine Chiasson, BSc, MA 902-470-7473 Lorraine.Chiasson@iwk.nshealth.ca

Locations
Layout table for location information
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
  Study Documents (Full-Text)

Documents provided by Allana, IWK Health Centre:
Study Protocol and Statistical Analysis Plan  [PDF] May 22, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Allana, Principle Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03871530    
Other Study ID Numbers: 1023951
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allana, IWK Health Centre:
Analgesia
Epidural
Labor
Obstetric Analgesia
Obstetrical
Additional relevant MeSH terms:
Layout table for MeSH terms
Labor Pain
Pain
Neurologic Manifestations