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Estimation of Pain During Epidural Analgesia During Labor

Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02551354
Acronym
PERIDANS
Enrollment
40
Registered
2015-09-16
Start date
2012-11-30
Completion date
2013-03-31
Last updated
2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Obstetric, Pain

Keywords

Labor, Obstetric, pain, pupil diameter, Visual Analogic Scale (VAS)

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).

Interventions

DEVICEPortable video pupillometer

Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pupil diameter variabilityFrom baseline to fifteen minutes after start of Epidural regional anesthesiaCompare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia. PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.

Secondary

MeasureTime frameDescription
pupil diameterFrom baseline to fifteen minutes after start of Epidural regional anesthesiaCompare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia
Visual Analogic Scale (VAS)From baseline to fifteen minutes after start of Epidural regional anesthesiaCompare the VAS measured at the end of contraction before Epidural regional anesthesia and after Epidural regional anesthesia.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026