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Effect of Epidural Analgesia on the Parameter ANI During Childbirth

NCT01505283 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-11-03

No results posted yet for this study

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.

Conditions

  • Labor Pain

Interventions

DRUG

NaCl 0.9%

epidural administration of 6 ml of NaCl 0.9%

DRUG

Sufentanil

epidural administration of sufentanil 10 µg

DRUG

lidocaine

epidural administration of lidocaine 50 mg

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Marc Fischler, MD · Hopital Foch

  • Morgan Le Guen, MD · Hopital Foch

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505283 on ClinicalTrials.gov