Deambulatory Epidural During the Labour

Study Overview
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Brief Summary
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Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.

Detailed Description
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Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.

Official Title
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Comparison of Two Different Peridural During the Labor and Effect of Deambulation

Conditions
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First Pregnancy

Intervention / Treatment
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* Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
* Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
* Procedure: Lumbar epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free written consent. ASA I or II, Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm VAS> 30 mm No contraindications to peridural Exclusion Criteria: Twin pregnancy, less than 36 weeks and 42 weeks Fetus in breech position Analgesia and sedation within 6h Contraindications to peridural

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL | Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml<br>* Levobupivacaine 0.1% + Sufentanil 0.2µg/ml<br>* Other names: control group;Procedure: Lumbar epidural analgesia<br>* Introduction of a catheter in lumbar epidural space<br>* Other names: labor analgesia;|
| Experimental: Ambulatory group<br>Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL | Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml<br>* Levobupivacaine 0.07% + Sufentanil 0.3µg/ml<br>* Other names: ambulatory group;Procedure: Lumbar epidural analgesia<br>* Introduction of a catheter in lumbar epidural space<br>* Other names: labor analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between peridural application and childbirth | This will be used to assess labor. | at delivery | 
| Caesarian | This will be used to assess labor. Was a caesarian necessary (yes-no) ? | at delivery | 
| Instrumentalisation | This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ? | at delivery | 
| Apgar score of the baby | Evaluation of the baby, using the Apgar score. This will be used to assess labor. | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bromage score | Modified Bromage score (Breen et al) >5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity). | 1h after the start of the peridural | 
| Romberg test | Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception). | 1h after the start of the peridural | 
| Arterial tension | Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient). | 1h after the start of the peridural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, primiparous patient, deambulation