Study Stopped
Difficulties of recrutment
Prediction of Chronic Pain by the Pain Monitor
D3C
Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)
2 other identifiers
observational
6
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2012
CompletedFirst Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2013
CompletedJanuary 29, 2018
January 1, 2018
1.5 years
April 17, 2012
January 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Prediction of chronic pain
Prediction of chronic pain by the measurement of skin conductance
one year after surgery
Secondary Outcomes (4)
Prediction of the postoperative pain
5 days postoperatively
Prediction of the postoperative antalgic requirement
5 days postoperatively
Prediction of the postoperative antalgic requirement by the genetic study
One year after surgery
Effect of remifentanil on skin conductance
One hour after anesthesia
Study Arms (1)
Thoracotomized patients
Interventions
Eligibility Criteria
Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)
You may qualify if:
- adult patients of both sexes
- planned pulmonary resection for cancer performed by a posterolateral thoracotomy
- thoracic epidural analgesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
CHU Strasbourg
Strasbourg, 67091, France
Hopital Foch
Suresnes, Île-de-France Region, 92151, France
Related Publications (1)
Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PMID: 18997532BACKGROUND
Biospecimen
Blood samples
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan Le Guen, MD
Hopital Foch
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2012
First Posted
May 10, 2012
Study Start
March 7, 2012
Primary Completion
September 7, 2013
Study Completion
September 7, 2013
Last Updated
January 29, 2018
Record last verified: 2018-01