NCT03730753

Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.

Detailed description

Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DEVICE	Programmed intermittent epidural bolus	Programmed intermittent epidural bolus added to patient controlled epidural analgesia
DEVICE	Continuous infusion	Continuous infusion added to patient controlled epidural analgesia

Timeline

• Start date: 2019-06-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2018-11-05
• Last updated: 2023-11-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study