Deambulatory Epidural During the Labour

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

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

Study Overview

• Status: Completed
• Conditions: First Pregnancy
• Intervention / Treatment: Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml; Procedure: Lumbar epidural analgesia; Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1020
    • CHUB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: control group; Procedure: Lumbar epidural analgesia; Introduction of a catheter in lumbar epidural space; Other Names: labor analgesia
Experimental: Ambulatory group; Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL	Procedure: Lumbar epidural analgesia; Introduction of a catheter in lumbar epidural space; Other Names: labor analgesia; Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Other Names: ambulatory group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr Madeleine Wilwerth
• Investigators: Study Director: Philippe Vanderlinden, CHUB

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: epidural; primiparous patient; deambulation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Levobupivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: PDB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No