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

IWK Health Centre55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Labor Pain

Interventions

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

Coordinate BOTHER

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

Coordinate COTHER

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

Coordinate DOTHER

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

Coordinate EOTHER

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

Coordinate FOTHER

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

Coordinate GOTHER

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

Coordinate HOTHER

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

Coordinate IOTHER

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

Coordinate JOTHER

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

Coordinate KOTHER

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

Coordinate LOTHER

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

Coordinate MOTHER

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

Coordinate NOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Maternal satisfaction score

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

Time frame: 24 hours following delivery

Number of clinician administered rescue boluses

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

Time frame: 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

Time frame: Start of labour epidural to delivery time

Data from ClinicalTrials.gov

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