COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Chronic Pain by the Pain Monitor (D3C)

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. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
France
Hopital Foch
Suresnes, Ile De France, France, 92151
CHU Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
Hopital Foch
Investigators
Layout table for investigator information
Principal Investigator: Morgan Le Guen, MD Hopital Foch
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01595711    
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:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations