Skip to main content
OpenTrials
Completed

NCT Number: NCT03407209

Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hopital

Caen, France

About this study

Local anesthetic used: levobupivacaine 0,625mg/ml

Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.

Randomization between:

  • PEIB:
  • 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

or

  • FREE programming: 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

Supervision and care consistent with french expert conference of the SFAR (Société Française d'Anesthésie-Réanimation) on management of women under epidural analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

consumption of local anesthetic measurement

Other

consumption of local anesthetic measurement in both groups

Primary outcomes

  1. consumption of local anesthetic

    Time frame: during delivery

Secondary outcomes

  1. Incidence of motor block

    Time frame: during delivery

  2. Incidence of dystocia

    Time frame: during delivery

  3. Incidence of instrumental delivery

    Time frame: during delivery

  4. Incidence of caesarian

    Time frame: during delivery

  5. Incidence of oxytocin administration

    Time frame: during delivery

  6. the evaluation of pain by a numerical scale rated from 0 to 10

    Time frame: during delivery

  7. Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience

    Time frame: during delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: FREE BOLI

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.