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Prediction of Chronic Pain by the Pain Monitor (D3C)

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ClinicalTrials.gov Identifier: NCT01595711
Recruitment Status : Terminated (Difficulties of recrutment)
First Posted : May 10, 2012
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.


Condition or disease Intervention/treatment
Surgery Device: Pain Monitor

Study Type : Observational
Actual Enrollment : 6 participants
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)
Actual Study Start Date : March 7, 2012
Actual Primary Completion Date : September 7, 2013
Actual Study Completion Date : September 7, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Group/Cohort Intervention/treatment
Thoracotomized patients Device: Pain Monitor
Measurement of cutaneous conductance



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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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


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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

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


Locations
France
Hopital Foch
Suresnes, Ile De France, France, 92151
CHU Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch

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 Posted: May 10, 2012    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

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