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

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.

Study Overview

• Status: Terminated
• Conditions: Labor Pain
• Intervention / Treatment: Drug: NaCl 0.9%; Drug: Sufentanil; Drug: lidocaine

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Suresnes, Ile de France, France, 92151
      • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours
Effects of anxiety score on ANI	The secondary objective is to study the effects of anxiety on the parameter ANI.	2 hours

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Sufentanil
• Other Study ID Numbers: 2010/20; 2011-A00962-39 (Other Identifier: ANSM)