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

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind randomized trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coordinate A<br>PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL | Other: Coordinate A<br>* PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL<br>|
| Experimental: Coordinate B<br>PIEB Next Bolus: 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL | Other: Coordinate B<br>* PIEB Next Bolus: 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL<br>|
| Experimental: Coordinate C<br>PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL | Other: Coordinate C<br>* PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL<br>|
| Experimental: Coordinate D<br>PIEB Next Bolus: 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL | Other: Coordinate D<br>* PIEB Next Bolus: 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL<br>|
| Experimental: Coordinate E<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL | Other: Coordinate E<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL<br>|
| Experimental: Coordinate F<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL | Other: Coordinate F<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL<br>|
| Experimental: Coordinate G<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL | Other: Coordinate G<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL<br>|
| Experimental: Coordinate H<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL | Other: Coordinate H<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL<br>|
| Experimental: Coordinate I<br>PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL | Other: Coordinate I<br>* PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL<br>|
| Experimental: Coordinate J<br>PIEB Next Bolus: 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL | Other: Coordinate J<br>* PIEB Next Bolus: 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL<br>|
| Experimental: Coordinate K<br>PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL | Other: Coordinate K<br>* PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL<br>|
| Experimental: Coordinate L<br>PIEB Next Bolus: 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL | Other: Coordinate L<br>* PIEB Next Bolus: 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL<br>|
| Experimental: Coordinate M<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL | Other: Coordinate M<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL<br>|
| Experimental: Coordinate N<br>PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL | Other: Coordinate N<br>* PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Epidural, Labor, Obstetric Analgesia, Obstetrical