Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Not Applicable

Recruiting

• Conditions: Labor Pain
• Interventions: Device: Continuous infusion; Device: Programmed intermittent epidural bolus

• Registration Number: NCT03730753
• Lead Sponsor: Université de Sherbrooke

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Study Start: 2019-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Pregnant nulliparous or multiparous woman in labour
• Age ≥18 years
• Obtained consent for epidural analgesia
• ASA classification I-II-III
• Early labour (cervical dilation ≤6cm)

Exclusion Criteria

• Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
• Prematurity (<36 weeks of gestation)
• Multiple gestation
• Fentanyl allergy or hypersensitivity
• Patient unable to understand the PCEA
• Fetal breech position
• Maternal cardiac pathology and contraindication to Valsalva manoeuvre
• Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
• Intrathecal catheter or intravascular catheter
• Accidental dural puncture
• Patient refusal
• Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Continuous infusion	Continuous infusion + patient controlled epidural analgesia
Study group	Programmed intermittent epidural bolus	Programmed intermittent epidural bolus + patient controlled analgesia

Primary Outcome Measures

Name	Time	Method
Dose of bupivacaine in milligrams per hour	1 day	Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours

Secondary Outcome Measures

Name	Time	Method
Time lapse before the first PCEA request after the epidural connection	1 day	Time lapse before the first PCEA request after the epidural connection
First stage	1 day	Duration of the first stage of labour
Evaluation of pain	1 day	Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable
Assisted vaginal delivery	1 day	Number of assisted vaginal delivery (vacuum, forceps)
PCEA boluses requested	1 day	PCEA boluses requested
Second stage	1 day	Duration of the second stage of labour
Cesarean section	1 day	Number of unplanned cesarean section
Anesthesiologist manual bolus	1 day	Total boluses by the anesthesiologist
PCEA boluses received	1 day	PCEA boluses received
Patient satisfaction	1 day	Satisfaction of the analgesia provided by the epidural on a visual analog scale of 0-100, 0/100 being no satisfaction at all and 100/100 being entirely satisfied
Motor blockade	1 day	Number of patients with a Bromage score ≥1

Trial Locations

Locations (1)

CHUS; 🇨🇦 Sherbrooke, Quebec, Canada