NCT03871530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

March 1, 2019

Last Update Submit

September 22, 2022

Conditions

Labor Pain

Keywords

AnalgesiaEpiduralLaborObstetric AnalgesiaObstetrical

Outcome Measures

Primary Outcomes (3)

  • Maternal satisfaction score

    quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied

    24 hours following delivery

  • Number of clinician administered rescue boluses

    Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump

    Start of labour epidural to delivery time

  • 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

    Start of labour epidural to delivery time

Study Arms (14)

Coordinate A

EXPERIMENTAL

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

Other: Coordinate A

Coordinate B

EXPERIMENTAL

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

Other: Coordinate B

Coordinate C

EXPERIMENTAL

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

Other: Coordinate C

Coordinate D

EXPERIMENTAL

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

Other: Coordinate D

Coordinate E

EXPERIMENTAL

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

Other: Coordinate E

Coordinate F

EXPERIMENTAL

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

Other: Coordinate F

Coordinate G

EXPERIMENTAL

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

Other: Coordinate G

Coordinate H

EXPERIMENTAL

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

Other: Coordinate H

Coordinate I

EXPERIMENTAL

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

Other: Coordinate I

Coordinate J

EXPERIMENTAL

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

Other: Coordinate J

Coordinate K

EXPERIMENTAL

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

Other: Coordinate K

Coordinate L

EXPERIMENTAL

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

Other: Coordinate L

Coordinate M

EXPERIMENTAL

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

Other: Coordinate M

Coordinate N

EXPERIMENTAL

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

Other: Coordinate N

Interventions

Coordinate AOTHER

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

Coordinate A
Coordinate BOTHER

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

Coordinate B
Coordinate COTHER

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

Coordinate C
Coordinate DOTHER

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

Coordinate D
Coordinate EOTHER

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

Coordinate E
Coordinate FOTHER

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

Coordinate F
Coordinate GOTHER

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

Coordinate G
Coordinate HOTHER

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

Coordinate H
Coordinate IOTHER

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

Coordinate I
Coordinate JOTHER

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

Coordinate J
Coordinate KOTHER

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

Coordinate K
Coordinate LOTHER

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

Coordinate L
Coordinate MOTHER

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

Coordinate M
Coordinate NOTHER

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

Coordinate N

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous,
  • English speaking
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

  • Munro A, George RB, Andreou P. An Innovative Approach to Determine Programmed Intermittent Epidural Bolus Pump Settings for Labor Analgesia: A Randomized Controlled Trial. Anesth Analg. 2024 Sep 1;139(3):545-554. doi: 10.1213/ANE.0000000000006813. Epub 2024 Aug 16.

    PMID: 38905148DERIVED

MeSH Terms

Conditions

Labor PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double-blind randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 12, 2019

Study Start

April 29, 2019

Primary Completion

October 15, 2020

Study Completion

June 30, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)