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CompletedNCT03407209FREE BOLIUpdated Jan 23, 2018

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

An interventional study of consumption of local anesthetic measurement in Delivery, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
462
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Delivery

Keywords

  • Epidural analgesia
  • Patient Controlled Epidural Analgesia (PCEA)
  • Patient Epidural Intermittent Bolus (PEIB)
  • Local anesthetics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
  • Multiple pregnancy
  • Fetal death in utero
  • Programmed or in emergency caesarian
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
462 participants (actual)

Study arms

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

    * 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

  • Experimental
    FREE programming - levobupivacaine anesthetics: 0.625 mg / ml

    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

  • Otherconsumption of local anesthetic measurement

    consumption of local anesthetic measurement in both groups

05

What researchers measure

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

06

Study locations

1 site
  • Caen University Hopital
    Caen, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407209
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Nov 6, 2016
Primary completion
Aug 16, 2017
Completion
Jan 1, 2018
Last update
Jan 23, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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