Clinical trial NCT03730753: Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia
Official title: Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose of bupivacaine in milligrams per hour
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of pain
timeFrame: 1 day
measure: Anesthesiologist manual bolus
timeFrame: 1 day
measure: PCEA boluses received
timeFrame: 1 day
measure: PCEA boluses requested
timeFrame: 1 day
measure: Time lapse before the first PCEA request after the epidural connection
timeFrame: 1 day
measure: First stage
timeFrame: 1 day
measure: Second stage
timeFrame: 1 day
measure: Assisted vaginal delivery
timeFrame: 1 day
measure: Cesarean section
timeFrame: 1 day
measure: Motor blockade
timeFrame: 1 day
measure: Patient satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Geneviève Rivard, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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