SurgeryD3CNCT01595711
Prediction of Chronic Pain by the Pain Monitor
An observational study of Surgery, run by Hopital Foch at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery
- What is being tested?
- Pain Monitor
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Mar 2012to 7 Sep 2013
- 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: Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)
Who may be able to join
- adult patients of both sexes
- planned pulmonary resection for cancer performed by a posterolateral thoracotomy
- thoracic epidural analgesia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Strasbourg
Strasbourg, 67091
Hopital Foch
Suresnes, Île-de-France Region, 92151
About this study
Official title: Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)
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.
- Conditions
- Surgery
- Being tested
- Pain Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain MonitorDevice
Measurement of cutaneous conductance
| Study group | Role | What they receive |
|---|---|---|
| Thoracotomized patients | Not described Receives: Device: Pain Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of chronic pain
Prediction of chronic pain by the measurement of skin conductance
Measured: one year after surgery
Secondary outcomes (4)
Prediction of the postoperative pain
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.
Measured: 5 days postoperatively
Prediction of the postoperative antalgic requirement
Prediction of the postoperative analgesic requirement by the measurement of skin conductance. The analgesic requirement is evaluated by the amount of epidural analgesics.
Measured: 5 days postoperatively
Prediction of the postoperative antalgic requirement by the genetic study
Prediction of the postoperative antalgic requirement by the genetic study
Measured: One year after surgery
Effect of remifentanil on skin conductance
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.
Measured: One hour after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study start7 Mar 2012
- Primary completion7 Sep 2013
- Study completion7 Sep 2013
Why it stopped: Difficulties of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595711
- Sponsor's protocol ID
- 2011/37
- Other IDs
- 2011-A00750-41
- Acronym
- D3C
- Status last verified
- Jan 2018
- First submitted
- 17 Apr 2012
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PubMed 18997532
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)
- ClinicalTrials.gov ID
- NCT01595711
- Acronym / sponsor ID
- D3C / 2011/37
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties of recrutment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 7 Mar 2012 (actual)
- Primary completion
- 7 Sep 2013 (actual)
- Study completion
- 7 Sep 2013 (actual)
- First posted
- 10 May 2012 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracotomized patients | – | Device: Pain Monitor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo a lung surgical procedure (thoracotomized patients)
Key inclusion criteria (3 listed)
- adult patients of both sexes
- planned pulmonary resection for cancer performed by a posterolateral thoracotomy
- thoracic epidural analgesia
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Pain MonitorMeasurement of cutaneous conductance | Device | Thoracotomized patients |
Primary outcome
Prediction of chronic pain
Time frame: one year after surgery
Prediction of chronic pain by the measurement of skin conductance
4 secondary outcomes
Prediction of the postoperative pain
Time frame: 5 days postoperatively
Prediction of the postoperative antalgic requirement
Time frame: 5 days postoperatively
Prediction of the postoperative antalgic requirement by the genetic study
Time frame: One year after surgery
Effect of remifentanil on skin conductance
Time frame: One hour after anesthesia
Results and safety
The study was stopped early (reason given: Difficulties of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 18997532Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
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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.
Morgan Le Guen, MD principal investigator
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Hopital Foch at 2 sites 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Difficulties of recrutment). Results are not available in the source record.
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?
Prediction of chronic pain (time frame: one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595711, which also lists 1 linked publication.
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 29 Jan 2018.