NCT02015858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

December 10, 2013

Last Update Submit

October 28, 2016

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Pain monitor evaluation of pain

    Comparison between Pain monitor index and auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain)

    1 hour

Secondary Outcomes (1)

  • Pain intensity

    1 hour

Study Arms (2)

Epidural analgesia

Postoperative patients with epidural analgesia

Procedure: Chest drain withdrawalDevice: Pain Monitor

Oral analgesics

Postoperative patients with oral analgesics

Procedure: Chest drain withdrawalDevice: Pain Monitor

Interventions

Chest drain withdrawalPROCEDURE
Epidural analgesiaOral analgesics
Pain MonitorDEVICE
Also known as: Measurement of Pain Monitor index
Epidural analgesiaOral analgesics

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung surgical patients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Fischler

    Hôpital Foch

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 19, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)