Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Université de Sherbrooke

Status: Enrolling

Conditions: Labor Pain

Treatments: Device: Continuous infusion; Device: Programmed intermittent epidural bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT03730753

2018 - 2686

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Control group

Active Comparator group

Description:

Continuous infusion + patient controlled epidural analgesia

Treatment:

Device: Continuous infusion

Study group

Experimental group

Description:

Programmed intermittent epidural bolus + patient controlled analgesia

Treatment:

Device: Programmed intermittent epidural bolus