Estimation of Pain During Epidural Analgesia During Labor | NCT02551354

Studies
Estimation of Pain During Epidural Analgesia During Labor

NCT02551354

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Sep 16, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Labor, Obstetric
Pain

Interventions

Portable video pupillometer

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Sep 11, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2015

Last Update Posted Date

Sep 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients	Experimental	Pain assess by : Visual Analogic Scale (VAS). Portable video pupillometer	Device: Portable video pupillometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Portable video pupillometer	Device	Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
pupil diameter	Compare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia	From baseline to fifteen minutes after start of Epidural regional anesthesia
Visual Analogic Scale (VAS)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Charier, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint-Etienne		Saint-Etienne		42055	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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