Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Programmed intermittent epidural bolus
* Device: Continuous infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Continuous infusion + patient controlled epidural analgesia | Device: Continuous infusion<br>* Continuous infusion added to patient controlled epidural analgesia<br>|
| Experimental: Study group<br>Programmed intermittent epidural bolus + patient controlled analgesia | Device: Programmed intermittent epidural bolus<br>* Programmed intermittent epidural bolus added to patient controlled epidural analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of bupivacaine in milligrams per hour | Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours | 1 day | 

Secondary Outcome Measures

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