Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Labor Pain Clinical Trial

— APD-ANI  

Official title:

Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01505283
• Other study ID #: 2010/20
• Secondary ID: 2011-A00962-39
• Status: Terminated
• Phase: N/A
• First received: January 4, 2012
• Last updated: November 2, 2016
• Start date: December 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• NaCl 0.9%
epidural administration of 6 ml of NaCl 0.9%
• Sufentanil
epidural administration of sufentanil 10 µg
• lidocaine
epidural administration of lidocaine 50 mg

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the ANI parameter with the VAS during labour	The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.	2 hours	No
Secondary	Effects of epidural sufentanil and of epidural local anesthetic on ANI	The secondary objective is to compare the effects of epidural sufentanil and a local anesthetic on the parameter ANI.	2 hours	No
Secondary	Effects of anxiety score on ANI	The secondary objective is to study the effects of anxiety on the parameter ANI.	2 hours	No