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Effect of Epidural Analgesia on the Parameter ANI During Childbirth

NCT ID: NCT01505283

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group Saline

Epidural administration of saline

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

epidural administration of 6 ml of NaCl 0.9%

Group Sufentanil

Epidural administration of sufentanil

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

epidural administration of sufentanil 10 µg

Group Lidocaine

Epidural administration of lidocaine

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

epidural administration of lidocaine 50 mg

Interventions

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NaCl 0.9%

epidural administration of 6 ml of NaCl 0.9%

Intervention Type DRUG

Sufentanil

epidural administration of sufentanil 10 µg

Intervention Type DRUG

lidocaine

epidural administration of lidocaine 50 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch

Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2011-A00962-39

Identifier Type: OTHER

Identifier Source: secondary_id

2010/20

Identifier Type: -

Identifier Source: org_study_id