NCT01505283

Brief Summary

There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS). Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

3.6 years

First QC Date

January 4, 2012

Last Update Submit

November 2, 2016

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Comparison of the ANI parameter with the VAS during labour

    The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.

    2 hours

Secondary Outcomes (2)

  • Effects of epidural sufentanil and of epidural local anesthetic on ANI

    2 hours

  • Effects of anxiety score on ANI

    2 hours

Study Arms (3)

Group Saline

PLACEBO COMPARATOR

Epidural administration of saline

Drug: NaCl 0.9%

Group Sufentanil

EXPERIMENTAL

Epidural administration of sufentanil

Drug: Sufentanil

Group Lidocaine

EXPERIMENTAL

Epidural administration of lidocaine

Drug: lidocaine

Interventions

NaCl 0.9%DRUG

epidural administration of 6 ml of NaCl 0.9%

Group Saline
SufentanilDRUG

epidural administration of sufentanil 10 µg

Group Sufentanil
lidocaineDRUG

epidural administration of lidocaine 50 mg

Group Lidocaine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years,
  • ASA I or II,
  • No history of cardiovascular or respiratory disease
  • No cardiovascular medication
  • No treatment with a tocolytic agent(salbutamol, nicardipine)
  • Desiring epidural analgesia at the early phase of labor pain

You may not qualify if:

  • Too fast labour
  • A pain score at or above 70 on the pain scale
  • A disturbed EKG signal or extrasystoles
  • Pace-Maker
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, Île-de-France Region, 92151, France

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Sodium ChlorideSufentanilLidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

  • Morgan Le Guen, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(1)