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

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Other: Coordinate G; Other: Coordinate C; Other: Coordinate F; Other: Coordinate I; Other: Coordinate E; Other: Coordinate N; Other: Coordinate H; Other: Coordinate A; Other: Coordinate B; Other: Coordinate D; Other: Coordinate J; Other: Coordinate M; Other: Coordinate L; Other: Coordinate K

• Registration Number: NCT03871530
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Study Start: 2019-04-29
• Primary Completion: 2020-10-15
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coordinate G	Coordinate G	PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
Coordinate C	Coordinate C	PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Coordinate F	Coordinate F	PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
Coordinate I	Coordinate I	PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Coordinate E	Coordinate E	PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
Coordinate N	Coordinate N	PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Coordinate H	Coordinate H	PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
Coordinate A	Coordinate A	PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Coordinate B	Coordinate B	PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Coordinate D	Coordinate D	PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Coordinate J	Coordinate J	PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Coordinate M	Coordinate M	PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Coordinate L	Coordinate L	PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Coordinate K	Coordinate K	PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL

Primary Outcome Measures

Name	Time	Method
Number of clinician administered rescue boluses	Start of labour epidural to delivery time	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	Start of labour epidural to delivery time	Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery
Maternal satisfaction score	24 hours following delivery	quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada