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Prediction of Chronic Pain by the Pain Monitor (D3C)

This study is currently recruiting participants.
Verified November 2016 by Hopital Foch
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595711
First Posted: May 10, 2012
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose

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.


Condition Intervention
Surgery Device: Pain Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Prediction of chronic pain [ Time Frame: one year after surgery ]
    Prediction of chronic pain by the measurement of skin conductance


Secondary Outcome Measures:
  • Prediction of the postoperative pain [ Time Frame: 5 days postoperatively ]
    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.

  • Prediction of the postoperative antalgic requirement [ Time Frame: 5 days postoperatively ]
    Prediction of the postoperative analgesic requirement by the measurement of skin conductance. The analgesic requirement is evaluated by the amount of epidural analgesics.

  • Prediction of the postoperative antalgic requirement by the genetic study [ Time Frame: One year after surgery ]
    Prediction of the postoperative antalgic requirement by the genetic study

  • Effect of remifentanil on skin conductance [ Time Frame: One hour after anesthesia ]
    Skin conductance is measured before and after a calibrated noxious stimulus. This test is performed after the induction of anesthesia (propofol) and a first time before remifentanil administration and a second time after.


Biospecimen Retention:   Samples With DNA
Blood samples

Estimated Enrollment: 230
Study Start Date: April 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thoracotomized patients Device: Pain Monitor
Measurement of cutaneous conductance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595711


Contacts
Contact: Marc Fischler, MD 4652442 ext 0331 m.fischler@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, Ile de France, France, 92151
Contact: Morgan Le Guen, MD    46252442 ext 00331    m.leguen@hopital-foch.org   
CHU Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Jean Hentz, MD    69551271 ext 003    jean.hentz@chru-strasbourg.fr   
Principal Investigator: Jean Hentz, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01595711     History of Changes
Other Study ID Numbers: 2011/37
2011-A00750-41 ( Other Identifier: ANSM )
First Submitted: April 17, 2012
First Posted: May 10, 2012
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms