Prediction of Chronic Pain by the Pain Monitor

Terminated

• Conditions: Surgery
• Interventions: Device: Pain Monitor

• Registration Number: NCT01595711
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Primary Completion: 2013-09-07
• Study Completion: 2013-09-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• adult patients of both sexes
• planned pulmonary resection for cancer performed by a posterolateral thoracotomy
• thoracic epidural analgesia

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracotomized patients	Pain Monitor	-

Primary Outcome Measures

Name	Time	Method
Prediction of chronic pain	one year after surgery	Prediction of chronic pain by the measurement of skin conductance

Secondary Outcome Measures

Name	Time	Method
Prediction of the postoperative pain	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.
Prediction of the postoperative antalgic requirement by the genetic study	One year after surgery	Prediction of the postoperative antalgic requirement by the genetic study
Prediction of the postoperative antalgic requirement	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.
Effect of remifentanil on skin conductance	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.

Trial Locations

Locations (2)

Hopital Foch; 🇫🇷 Suresnes, Ile De France, France

CHU Strasbourg; 🇫🇷 Strasbourg, France