Prediction of Chronic Pain by the Pain Monitor

Surgery Clinical Trial

— D3C  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01595711
• Other study ID #: 2011/37
• Secondary ID: 2011-A00750-41
• Status: Terminated
• Phase: N/A
• First received: April 17, 2012
• Last updated: January 26, 2018
• Start date: March 7, 2012
• Est. completion date: September 7, 2013

Study information

• Verified date: January 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 7, 2013
• Est. primary completion date: September 7, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Surgery

Intervention

Device:
• Pain Monitor
Measurement of cutaneous conductance

Locations

Country	Name	City	State
France	CHU Strasbourg	Strasbourg
France	Hopital Foch	Suresnes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of chronic pain	Prediction of chronic pain by the measurement of skin conductance	one year after surgery
Secondary	Prediction of the postoperative pain	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
Secondary	Prediction of the postoperative antalgic requirement	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
Secondary	Prediction of the postoperative antalgic requirement by the genetic study	Prediction of the postoperative antalgic requirement by the genetic study	One year after surgery
Secondary	Effect of remifentanil on skin conductance	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