Clinical trial NCT02551354: Estimation of Pain During Epidural Analgesia During Labor
Official title: Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Obstetric
Pain
Keywords: Labor, Obstetric
pain
pupil diameter
Visual Analogic Scale (VAS)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.

Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).

The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.

There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).


Eligibility criteria: Inclusion Criteria:

* Obstetrical Labor
* Able to rate their pain using VAS
* dilatation of the cervix under 6 centimeters
* Written consent

Exclusion Criteria:

* - Not having a anesthesia consultation during the 48 hours before delivery
* With a contra-indication for an epidural
* To which an incident occurred during a previous epidural using a medication used in the study
* Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
* general anesthesia in the seven days preceding delivery
* Carry a pacemaker or heart grafted
* Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
* Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
* Treated for hypertension by receptor antagonists of angiotensin type 2
* anti-arrhythmic treatment or blocker,
* Refusing to participate in the study
* With a contra-indication for the use of ropivacaine and sufentanil.

Primary outcomes:
measure: Pupil diameter variability
timeFrame: From baseline to fifteen minutes after start of Epidural regional anesthesia
Secondary outcomes:
measure: pupil diameter
timeFrame: From baseline to fifteen minutes after start of Epidural regional anesthesia
measure: Visual Analogic Scale (VAS)
timeFrame: From baseline to fifteen minutes after start of Epidural regional anesthesia
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David Charier, MD
role: PRINCIPAL_INVESTIGATOR
References: