Deambulatory Epidural During the Labour

Dr Madeleine Wilwerth

Status and phase: Completed; Phase 3

Conditions: First Pregnancy

Treatments: Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml; Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Procedure: Lumbar epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02264834

PDB001

Details and patient eligibility

About

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

Full description

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

Enrollment: 164 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups

Control group

Active Comparator group

Description:

Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL

Treatment:

Procedure: Lumbar epidural analgesia

Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

Ambulatory group

Experimental group

Description:

Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL

Treatment:

Procedure: Lumbar epidural analgesia

Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml