Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor

Completed

• Conditions: Chest Pain
• Interventions: Procedure: Chest drain withdrawal; Device: Pain Monitor

• Registration Number: NCT02015858
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epidural analgesia	Pain Monitor	Postoperative patients with epidural analgesia
Oral analgesics	Chest drain withdrawal	Postoperative patients with oral analgesics
Epidural analgesia	Chest drain withdrawal	Postoperative patients with epidural analgesia
Oral analgesics	Pain Monitor	Postoperative patients with oral analgesics

Primary Outcome Measures

Name	Time	Method
Pain monitor evaluation of pain	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

Name	Time	Method
Pain intensity	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

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France