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Clinical Trials/NCT01505283
NCT01505283
Terminated
Not Applicable

Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Hopital Foch1 site in 1 country42 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
NaCl 0.9%
Conditions
Labor Pain
Sponsor
Hopital Foch
Enrollment
42
Locations
1
Primary Endpoint
Comparison of the ANI parameter with the VAS during labour
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Group Saline

Epidural administration of saline

Intervention: NaCl 0.9%

Group Sufentanil

Epidural administration of sufentanil

Intervention: Sufentanil

Group Lidocaine

Epidural administration of lidocaine

Intervention: lidocaine

Outcomes

Primary Outcomes

Comparison of the ANI parameter with the VAS during labour

Time Frame: 2 hours

The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.

Secondary Outcomes

  • Effects of epidural sufentanil and of epidural local anesthetic on ANI(2 hours)
  • Effects of anxiety score on ANI(2 hours)

Study Sites (1)

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