Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505283

Acronym

APD-ANI

Enrollment

Registered

2012-01-06

Start date

2011-12-31

Completion date

2015-07-31

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

DRUGNaCl 0.9%

epidural administration of 6 ml of NaCl 0.9%

DRUGSufentanil

epidural administration of sufentanil 10 µg

DRUGlidocaine

epidural administration of lidocaine 50 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026