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Clinical Trials/NCT03730753
NCT03730753
Recruiting
Not Applicable

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

Université de Sherbrooke1 site in 1 country200 target enrollmentJune 1, 2019
ConditionsLabor Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Université de Sherbrooke
Enrollment
200
Locations
1
Primary Endpoint
Dose of bupivacaine in milligrams per hour
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Geneviève Rivard

Principal investigator

Université de Sherbrooke

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

Outcomes

Primary Outcomes

Dose of bupivacaine in milligrams per hour

Time Frame: 1 day

Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours

Secondary Outcomes

  • Time lapse before the first PCEA request after the epidural connection(1 day)
  • First stage(1 day)
  • Evaluation of pain(1 day)
  • Assisted vaginal delivery(1 day)
  • PCEA boluses requested(1 day)
  • Second stage(1 day)
  • Cesarean section(1 day)
  • Anesthesiologist manual bolus(1 day)
  • PCEA boluses received(1 day)
  • Patient satisfaction(1 day)
  • Motor blockade(1 day)

Study Sites (1)

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