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Effect of Epidural Analgesia on the Parameter ANI During Childbirth (APD-ANI)

Primary Purpose

Labor Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NaCl 0.9%
Sufentanil
lidocaine
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Labor Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group Saline

Group Sufentanil

Group Lidocaine

Arm Description

Epidural administration of saline

Epidural administration of sufentanil

Epidural administration of lidocaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effects of epidural sufentanil and of epidural local anesthetic on ANI
The secondary objective is to compare the effects of epidural sufentanil and a local anesthetic on the parameter ANI.
Effects of anxiety score on ANI
The secondary objective is to study the effects of anxiety on the parameter ANI.

Full Information

First Posted
January 4, 2012
Last Updated
November 2, 2016
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT01505283
Brief Title
Effect of Epidural Analgesia on the Parameter ANI During Childbirth
Acronym
APD-ANI
Official Title
Effect of Epidural Analgesia on the Parameter ANI During Childbirth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Saline
Arm Type
Placebo Comparator
Arm Description
Epidural administration of saline
Arm Title
Group Sufentanil
Arm Type
Experimental
Arm Description
Epidural administration of sufentanil
Arm Title
Group Lidocaine
Arm Type
Experimental
Arm Description
Epidural administration of lidocaine
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Intervention Description
epidural administration of 6 ml of NaCl 0.9%
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
epidural administration of sufentanil 10 µg
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
epidural administration of lidocaine 50 mg
Primary Outcome Measure Information:
Title
Comparison of the ANI parameter with the VAS during labour
Description
The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Effects of epidural sufentanil and of epidural local anesthetic on ANI
Description
The secondary objective is to compare the effects of epidural sufentanil and a local anesthetic on the parameter ANI.
Time Frame
2 hours
Title
Effects of anxiety score on ANI
Description
The secondary objective is to study the effects of anxiety on the parameter ANI.
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Too fast labour A pain score at or above 70 on the pain scale A disturbed EKG signal or extrasystoles Pace-Maker Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler, MD
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Morgan Le Guen, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
State/Province
Ile de France
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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Effect of Epidural Analgesia on the Parameter ANI During Childbirth

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