Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses (FREE BOLI)

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.

Study Overview

• Status: Completed
• Conditions: Delivery
• Intervention / Treatment: Other: consumption of local anesthetic measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; consumption of local anesthetic measurement in both groups
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; consumption of local anesthetic measurement in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
consumption of local anesthetic	during delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
the evaluation of pain by a numerical scale rated from 0 to 10	during delivery
Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience	during delivery

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2016
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Epidural analgesia; Patient Controlled Epidural Analgesia (PCEA); Patient Epidural Intermittent Bolus (PEIB); Local anesthetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2016-A01346-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No