Effect of Epidural Analgesia on the Parameter ANI During Childbirth (APD-ANI)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Effect of Epidural Analgesia on the Parameter ANI During Childbirth|
- Comparison of the ANI parameter with the VAS during labour [ Time Frame: 2 hours ] [ Designated as safety issue: No ]The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.
- Effects of epidural sufentanil and of epidural local anesthetic on ANI [ Time Frame: 2 hours ] [ Designated as safety issue: No ]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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]The secondary objective is to study the effects of anxiety on the parameter ANI.
|Study Start Date:||December 2011|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Group Saline
Epidural administration of saline
Drug: NaCl 0.9%
epidural administration of 6 ml of NaCl 0.9%
Experimental: Group Sufentanil
Epidural administration of sufentanil
epidural administration of sufentanil 10 µg
Experimental: Group Lidocaine
Epidural administration of lidocaine
epidural administration of lidocaine 50 mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505283
|Suresnes, Ile de France, France, 92151|
|Study Chair:||Marc Fischler, MD||Hopital Foch|
|Principal Investigator:||Morgan Le Guen, MD||Hopital Foch|