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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coordinate A
Coordinate B
Coordinate C
Coordinate D
Coordinate E
Coordinate F
Coordinate G
Coordinate H
Coordinate I
Coordinate J
Coordinate K
Coordinate L
Coordinate M
Coordinate N
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Analgesia, Epidural, Labor, Obstetric Analgesia, Obstetrical

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Coordinate A

Coordinate B

Coordinate C

Coordinate D

Coordinate E

Coordinate F

Coordinate G

Coordinate H

Coordinate I

Coordinate J

Coordinate K

Coordinate L

Coordinate M

Coordinate N

Arm Description

PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL

PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL

PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL

PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL

PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL

PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL

PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL

PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL

PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL

Outcomes

Primary Outcome Measures

Maternal satisfaction score
quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied
Number of clinician administered rescue boluses
Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump
Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered
Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery

Secondary Outcome Measures

Full Information

First Posted
March 1, 2019
Last Updated
September 22, 2022
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03871530
Brief Title
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Official Title
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Analgesia, Epidural, Labor, Obstetric Analgesia, Obstetrical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coordinate A
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Arm Title
Coordinate B
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Arm Title
Coordinate C
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Arm Title
Coordinate D
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Arm Title
Coordinate E
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
Arm Title
Coordinate F
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
Arm Title
Coordinate G
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
Arm Title
Coordinate H
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
Arm Title
Coordinate I
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Arm Title
Coordinate J
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Arm Title
Coordinate K
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Arm Title
Coordinate L
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Arm Title
Coordinate M
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Arm Title
Coordinate N
Arm Type
Experimental
Arm Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate A
Intervention Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate B
Intervention Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate C
Intervention Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Intervention Type
Other
Intervention Name(s)
Coordinate D
Intervention Description
PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate E
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate F
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
Intervention Type
Other
Intervention Name(s)
Coordinate G
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
Intervention Type
Other
Intervention Name(s)
Coordinate H
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate I
Intervention Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate J
Intervention Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate K
Intervention Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Intervention Type
Other
Intervention Name(s)
Coordinate L
Intervention Description
PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate M
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Intervention Type
Other
Intervention Name(s)
Coordinate N
Intervention Description
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Primary Outcome Measure Information:
Title
Maternal satisfaction score
Description
quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied
Time Frame
24 hours following delivery
Title
Number of clinician administered rescue boluses
Description
Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump
Time Frame
Start of labour epidural to delivery time
Title
Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered
Description
Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery
Time Frame
Start of labour epidural to delivery time

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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