PERIDANS: Estimation of Pain During Epidural Analgesia During Labor

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02551354

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Labor, Obstetric Pain	Device: Portable video pupillometer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients Pain assess by : Visual Analogic Scale (VAS). Portable video pupillometer	Device: Portable video pupillometer Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor

Arm

Intervention/Treatment

Experimental: Patients

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

Device: Portable video pupillometer

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

Outcome Measures

Primary Outcome Measures

Pupil diameter variability [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 Outcome Measures

pupil diameter [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
Visual Analogic Scale (VAS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Etienne		France	42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: David Charier, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02551354

Other Study ID Numbers:

1208078

First Posted:

Sep 16, 2015

Last Update Posted:

Sep 16, 2015

Last Verified:

Sep 1, 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Labor, Obstetric

pain

pupil diameter

Visual Analogic Scale (VAS)

Study Results

No Results Posted as of Sep 16, 2015