Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00962-39 | Other Identifier | ANSM |
Not provided
Not provided
recruitment difficulties
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Saline | Placebo Comparator | Epidural administration of saline |
|
| Group Sufentanil | Experimental | Epidural administration of sufentanil |
|
| Group Lidocaine | Experimental | Epidural administration of lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl 0.9% | Drug | epidural administration of 6 ml of NaCl 0.9% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effects of anxiety score on ANI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Morgan Le Guen, MD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | Île-de-France Region | 92151 | France |
Not provided
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D017409 | Sufentanil |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sufentanil |
| Drug |
epidural administration of sufentanil 10 µg |
|
| lidocaine | Drug | epidural administration of lidocaine 50 mg |
|
The secondary objective is to study the effects of anxiety on the parameter ANI.
| 2 hours |
| D017670 |
| Sodium Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |