NCT03871530

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain

Interventions

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

Timeline

• Start date: 2019-04-29
• Primary completion: 2020-10-15
• Completion: 2022-06-30
• First posted: 2019-03-12
• Last updated: 2022-09-26

Locations

1 site across 1 country: Canada