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Prediction of Chronic Pain by the Pain Monitor (D3C)

This study is currently recruiting participants.
Verified May 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01595711
First received: April 17, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  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:

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

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Prediction of chronic pain [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    Prediction of chronic pain by the measurement of skin conductance


Secondary Outcome Measures:
  • Prediction of the postoperative pain [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Prediction of the postoperative antalgic requirement by the genetic study

  • Effect of remifentanil on skin conductance [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]
    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: 120
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thoracotomized patients Device: Pain Monitor
Measurement of cutaneous conductance

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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    
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
Study First Received: April 17, 2012
Last Updated: May 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 19, 2013