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Completed

NCT Number: NCT02551354

Estimation of Pain During Epidural Analgesia During Labor

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).

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Key information

Conditions

Labor, Obstetric Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portable video pupillometer

Device

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

Primary outcomes

  1. Pupil diameter variability

    Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia

    Compare 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 outcomes

  1. pupil diameter

    Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia

    Compare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia

  2. Visual Analogic Scale (VAS)

    Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia

    Compare the VAS measured at the end of contraction before Epidural regional anesthesia and after Epidural regional anesthesia.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: PERIDANS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2015
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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