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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.
Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL |
|
| Ambulatory group | Experimental | Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine 0.1% + Sufentanil 0.2µg/ml | Drug | Levobupivacaine 0.1% + Sufentanil 0.2µg/ml |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Vanderlinden | CHUB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUB | Brussels | 1020 | Belgium |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D017409 | Sufentanil |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Levobupivacaine 0.07% + Sufentanil 0.3µg/ml | Drug | Levobupivacaine 0.07% + Sufentanil 0.3µg/ml |
|
|
| Lumbar epidural analgesia | Procedure | Introduction of a catheter in lumbar epidural space |
|
|
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 |
| Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |