Effect of Epidural Analgesia on the Parameter ANI During Childbirth (APD-ANI)

Hopital Foch

Status: Terminated

Conditions: Labor Pain

Treatments: Drug: Sufentanil; Drug: NaCl 0.9%; Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01505283

2010/20

2011-A00962-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 3 patient groups, including a placebo group

Group Saline

Placebo Comparator group

Description:

Epidural administration of saline

Treatment:

Drug: NaCl 0.9%

Group Sufentanil

Experimental group

Description:

Epidural administration of sufentanil

Treatment:

Drug: Sufentanil

Group Lidocaine

Experimental group

Description:

Epidural administration of lidocaine

Treatment:

Drug: lidocaine