Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Not Applicable

Terminated

• Conditions: Labor Pain
• Interventions: Drug: NaCl 0.9%; Drug: lidocaine; Drug: Sufentanil

• Registration Number: NCT01505283
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Saline	NaCl 0.9%	Epidural administration of saline
Group Lidocaine	lidocaine	Epidural administration of lidocaine
Group Sufentanil	Sufentanil	Epidural administration of sufentanil

Primary Outcome Measures

Name	Time	Method
Comparison of the ANI parameter with the VAS during labour	2 hours	The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.

Secondary Outcome Measures

Name	Time	Method
Effects of epidural sufentanil and of epidural local anesthetic on ANI	2 hours	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	2 hours	The secondary objective is to study the effects of anxiety on the parameter ANI.

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, Ile de France, France