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Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor (Pain Drain)

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ClinicalTrials.gov Identifier: NCT02015858
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.

Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.


Condition or disease Intervention/treatment
Chest Pain Procedure: Chest drain withdrawal Device: Pain Monitor

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Epidural analgesia
Postoperative patients with epidural analgesia
Procedure: Chest drain withdrawal
Device: Pain Monitor
Other Name: Measurement of Pain Monitor index

Oral analgesics
Postoperative patients with oral analgesics
Procedure: Chest drain withdrawal
Device: Pain Monitor
Other Name: Measurement of Pain Monitor index




Primary Outcome Measures :
  1. Pain monitor evaluation of pain [ Time Frame: 1 hour ]
    Comparison between Pain monitor index and auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain)


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 1 hour ]
    Evolution of Pain monitor index and of auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) during the chest tube withdrawal



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung surgical patients
Criteria

Inclusion Criteria:

  • patients undergoing removal of a chest tube after lung surgery,
  • patients able to indicate the pain score.

Exclusion Criteria:

  • pregnancy, lactation ,
  • insulin-dependent diabetes with dysautonomia,
  • central or peripheral neurological disease, agitation,
  • inability to understand the protocol,
  • inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities,
  • contra-indication to oral morphine ,
  • respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations
  • recent administration of neostigmine or of atropine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015858


Locations
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler Hôpital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02015858     History of Changes
Other Study ID Numbers: 2013/22
2013-A00612-43 ( Other Identifier: ANSM )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms