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

This study has been terminated.
(recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01505283
First received: January 4, 2012
Last updated: November 2, 2016
Last verified: November 2016
  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:


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.


Enrollment: 42
Study Start Date: December 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Adult)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505283

Locations
France
Hopital Foch
Suresnes, Ile de France, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
Principal Investigator: Morgan Le Guen, MD Hopital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01505283     History of Changes
Other Study ID Numbers: 2010/20  2011-A00962-39 
Study First Received: January 4, 2012
Last Updated: November 2, 2016
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
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on December 02, 2016