Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deambulatory Epidural During the Labour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02264834
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Madeleine Wilwerth, Brugmann University Hospital

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

Condition or disease Intervention/treatment Phase
First Pregnancy Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml Procedure: Lumbar epidural analgesia Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Peridural During the Labor and Effect of Deambulation
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
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
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Other Name: control group

Procedure: Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space
Other Name: labor analgesia

Experimental: Ambulatory group
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
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Other Name: ambulatory group

Procedure: Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space
Other Name: labor analgesia




Primary Outcome Measures :
  1. Time between peridural application and childbirth [ Time Frame: at delivery ]
    This will be used to assess labor.

  2. Caesarian [ Time Frame: at delivery ]
    This will be used to assess labor. Was a caesarian necessary (yes-no) ?

  3. Instrumentalisation [ Time Frame: 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) ?

  4. Apgar score of the baby [ Time Frame: at delivery ]
    Evaluation of the baby, using the Apgar score. This will be used to assess labor.


Secondary Outcome Measures :
  1. Bromage score [ Time Frame: 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).

  2. Romberg test [ Time Frame: 1h after the start of the peridural ]
    Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).

  3. Arterial tension [ Time Frame: 1h after the start of the peridural ]
    Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264834


Locations
Layout table for location information
Belgium
CHUB
Bruxelles, Belgium, 1020
Sponsors and Collaborators
Dr Madeleine Wilwerth
Investigators
Layout table for investigator information
Study Director: Philippe Vanderlinden CHUB

Layout table for additonal information
Responsible Party: Dr Madeleine Wilwerth, primary investigator, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02264834     History of Changes
Other Study ID Numbers: PDB001
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Madeleine Wilwerth, Brugmann University Hospital:
epidural
primiparous patient
deambulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Sufentanil
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local