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Completed

NCT Number: NCT03871530

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

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.

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Key information

Conditions

Labor Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coordinate A

Other

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

Coordinate B

Other

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

Coordinate C

Other

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

Coordinate D

Other

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

Coordinate E

Other

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

Coordinate F

Other

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

Coordinate G

Other

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

Coordinate H

Other

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

Coordinate I

Other

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

Coordinate J

Other

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

Coordinate K

Other

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

Coordinate L

Other

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

Coordinate M

Other

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

Coordinate N

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Mar 12, 2019
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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