Deambulatory Epidural During the Labour

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02264834

Enrollment

164

Registered

2014-10-15

Start date

2014-07-01

Completion date

2018-03-20

Last updated

2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Pregnancy

Keywords

epidural, primiparous patient, deambulation

Brief summary

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

Detailed description

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

Interventions

DRUGLevobupivacaine 0.1% + Sufentanil 0.2µg/ml

Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

DRUGLevobupivacaine 0.07% + Sufentanil 0.3µg/ml

Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

PROCEDURELumbar epidural analgesia

Introduction of a catheter in lumbar epidural space

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026