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

This study is currently recruiting participants.
Verified July 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01505283
First received: January 4, 2012
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Labor Pain
 Drug: NaCl 0.9%
Drug: Sufentanil
Drug: lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Comparison of the ANI parameter with the VAS during labour [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The secondary objective is to study the effects of anxiety on the parameter ANI.


Estimated Enrollment: 360
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group Saline
Epidural administration of saline
 Drug: NaCl 0.9%
epidural administration of 6 ml of NaCl 0.9%
Experimental: Group Sufentanil
Epidural administration of sufentanil
 Drug: Sufentanil
epidural administration of sufentanil 10 µg
Experimental: Group Lidocaine
Epidural administration of lidocaine
 Drug: lidocaine
epidural administration of lidocaine 50 mg

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505283

Contacts
Contact: Morgan Le Guen 46252442 ext 00331 m.leguen@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, Ile de France, France, 92151
Contact: Morgan Le Guen, MD     46252442 ext 00331     m.leguen@hopital-foch.org    
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
Principal Investigator: Morgan Le Guen, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01505283     History of Changes
Other Study ID Numbers: 2010/20
Study First Received: January 4, 2012
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Analgesics, Opioid
Analgesics
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 21, 2013