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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Delivery

Intervention / Treatment
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* Other: consumption of local anesthetic measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml<br>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<br>* consumption of local anesthetic measurement in both groups<br>|
| Experimental: FREE programming - levobupivacaine anesthetics: 0.625 mg / ml<br>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<br>* consumption of local anesthetic measurement in both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of local anesthetic |  | during delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local anesthetics, Epidural analgesia, Patient Controlled Epidural Analgesia (PCEA), Patient Epidural Intermittent Bolus (PEIB)