Prediction of Chronic Pain by the Pain Monitor | NCT01595711

Studies
Prediction of Chronic Pain by the Pain Monitor

NCT01595711

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Jan 29, 2018Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Surgery

Interventions

Pain Monitor

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

ID	Type	Description	Link
2011-A00750-41	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties of recrutment

Expanded Access Info

Start Date

Mar 7, 2012Actual

Primary Completion Date

Sep 7, 2013Actual

Completion Date

Sep 7, 2013Actual

First Submitted Date

Apr 17, 2012

First Submission Date that Met QC Criteria

May 8, 2012

First Posted Date

May 10, 2012Estimated

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

Jan 26, 2018

Last Update Posted Date

Jan 29, 2018Actual

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

The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo, Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the individual, with higher sensitivity and specificity than other available objective methods.

The skin conductance response to a calibrated noxious stimulus varies among patients. It defines two types of people depending on its magnitude.

The investigators assume that the importance of skin conductance response to a noxious stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thoracotomized patients			Device: Pain Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain Monitor	Device	Measurement of cutaneous conductance	Thoracotomized patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of chronic pain	Prediction of chronic pain by the measurement of skin conductance	one year after surgery

Secondary Outcomes

Measure	Description	Time Frame
Prediction of the postoperative pain	Prediction of the postoperative pain by the measurement of skin conductance. Postoperative pain is assessed (pain score) at least twice each day at rest and during mobilisation.	5 days postoperatively
Prediction of the postoperative antalgic requirement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients of both sexes
planned pulmonary resection for cancer performed by a posterolateral thoracotomy
thoracic epidural analgesia

Exclusion Criteria:

pregnancy,
morbid obesity,
insulin-dependent diabetes with dysautonomia,
inability to proceed with anesthesia using the BIS signal,
known allergy to remifentanil, propofol, atracurium or to levobupivacaine,
contra-indication to nefopam
contra-indication to ketoprofen

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morgan Le Guen, MD	Hopital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Strasbourg		Strasbourg		67091	France
Hopital Foch

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18997532	Background	Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.