Chest PainPain DrainNCT02015858
Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor
An observational study of Chest Pain, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Chest drain withdrawal and Pain Monitor
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung surgical patients
Who may be able to join
- patients undergoing removal of a chest tube after lung surgery,
- patients able to indicate the pain score.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia
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.
- Conditions
- Chest Pain
- Being tested
- Chest drain withdrawal, Pain Monitor
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest drain withdrawalProcedure or surgery
Pain MonitorDevice
Also called Measurement of Pain Monitor index
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Postoperative patients with epidural analgesia Receives: Procedure: Chest drain withdrawal; Device: Pain Monitor | |
| Oral analgesics | Postoperative patients with oral analgesics Receives: Procedure: Chest drain withdrawal; Device: Pain Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
Secondary outcomes (1)
Pain intensity
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015858
- Sponsor's protocol ID
- 2013/22
- Other IDs
- 2013-A00612-43
- Acronym
- Pain Drain
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia
- ClinicalTrials.gov ID
- NCT02015858
- Acronym / sponsor ID
- Pain Drain / 2013/22
- Conditions
- Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | – | Procedure: Chest drain withdrawal, Device: Pain MonitorPostoperative patients with epidural analgesia |
| Oral analgesics | – | Procedure: Chest drain withdrawal, Device: Pain MonitorPostoperative patients with oral analgesics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung surgical patients
Key inclusion criteria (2 listed)
- patients undergoing removal of a chest tube after lung surgery,
- patients able to indicate the pain score.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest drain withdrawal | Procedure or surgery | Epidural analgesia, Oral analgesics |
| Pain MonitorAlso: Measurement of Pain Monitor index | Device | Epidural analgesia, Oral analgesics |
Primary outcome
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)
1 secondary outcome
Pain intensity
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain monitor evaluation of pain (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.