Prediction of Chronic Pain by the Pain Monitor (D3C)

January 26, 2018 updated by: Hopital Foch

Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • CHU Strasbourg
    • Ile De France
      • Suresnes, Ile De France, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days postoperatively
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.
5 days postoperatively
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
One year after surgery
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.
One hour after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2012

Primary Completion (ACTUAL)

September 7, 2013

Study Completion (ACTUAL)

September 7, 2013

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (ESTIMATE)

May 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/37
  • 2011-A00750-41 (OTHER: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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