NCT03407209

Brief Summary

Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated. However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage. Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction. While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

March 7, 2017

Last Update Submit

January 22, 2018

Conditions

Delivery

Keywords

Epidural analgesiaPatient Controlled Epidural Analgesia (PCEA)Patient Epidural Intermittent Bolus (PEIB)Local anesthetics

Outcome Measures

Primary Outcomes (1)

  • consumption of local anesthetic

    during delivery

Secondary Outcomes (7)

  • Incidence of motor block

    during delivery

  • Incidence of dystocia

    during delivery

  • Incidence of instrumental delivery

    during delivery

  • Incidence of caesarian

    during delivery

  • Incidence of oxytocin administration

    during delivery

  • +2 more secondary outcomes

Study Arms (2)

PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml

SHAM COMPARATOR

* automatic hourly bolus: 8ml (5mg) on 3 min * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h

Other: consumption of local anesthetic measurement

FREE programming - levobupivacaine anesthetics: 0.625 mg / ml

EXPERIMENTAL

Epidural analgesia totally controlled by the patient * automatic hourly bolus: 0 * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h

Other: consumption of local anesthetic measurement

Interventions

consumption of local anesthetic measurementOTHER

consumption of local anesthetic measurement in both groups

FREE programming - levobupivacaine anesthetics: 0.625 mg / mlPEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women delivering
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age \>/= 18 years
  • Nulliparous
  • \>35 weeks of amenorrhea
  • In spontaneous or triggered labor

You may not qualify if:

  • Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
  • Multiple pregnancy
  • Fetal death in utero
  • Programmed or in emergency caesarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hopital

Caen, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

January 23, 2018

Study Start

November 6, 2016

Primary Completion

August 16, 2017

Study Completion

January 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)