Effect of Epidural Analgesia on the Parameter ANI During Childbirth (APD-ANI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01505283|
Recruitment Status : Terminated (recruitment difficulties)
First Posted : January 6, 2012
Last Update Posted : November 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Drug: NaCl 0.9% Drug: Sufentanil Drug: lidocaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Epidural Analgesia on the Parameter ANI During Childbirth|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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
- Comparison of the ANI parameter with the VAS during labour [ Time Frame: 2 hours ]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 ]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 ]The secondary objective is to study the effects of anxiety on the parameter ANI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505283
|Suresnes, Ile de France, France, 92151|
|Study Chair:||Marc Fischler, MD||Hopital Foch|
|Principal Investigator:||Morgan Le Guen, MD||Hopital Foch|