Labor Pain
Conditions
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.
Interventions
Programmed intermittent epidural bolus added to patient controlled epidural analgesia
DEVICEContinuous infusion
Continuous infusion added to patient controlled epidural analgesia
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Anesthesiologist manual bolus | 1 day | Total boluses by the anesthesiologist |
| PCEA boluses received | 1 day | PCEA boluses received |
| PCEA boluses requested | 1 day | PCEA boluses requested |
| 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) |
| Cesarean section | 1 day | Number of unplanned cesarean section |
| Motor blockade | 1 day | Number of patients with a Bromage score ≥1 |
| 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 |
| Second stage | 1 day | Duration of the second stage of labour |
Countries
Canada
Contacts
Primary ContactIsabelle Caron, Dr.
Backup ContactGeneviève Rivard, Dr.
Outcome results
None listed