NCT02551354

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 11, 2015

Last Update Submit

September 15, 2015

Conditions

Labor, ObstetricPain

Keywords

Labor, Obstetricpainpupil diameterVisual Analogic Scale (VAS)

Outcome Measures

Primary Outcomes (1)

  • Pupil diameter variability

    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.

    From baseline to fifteen minutes after start of Epidural regional anesthesia

Secondary Outcomes (2)

  • pupil diameter

    From baseline to fifteen minutes after start of Epidural regional anesthesia

  • Visual Analogic Scale (VAS)

    From baseline to fifteen minutes after start of Epidural regional anesthesia

Study Arms (1)

Patients

EXPERIMENTAL

Pain assess by : * Visual Analogic Scale (VAS). * Portable video pupillometer

Device: Portable video pupillometer

Interventions

Portable video pupillometerDEVICE

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

Patients

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Charier, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 16, 2015

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations

FR(1)