Pain, PostoperativeNCT00305136
Advancement of Psychophysics of Pain Modulation From Lab to Clinic: Constructing Susceptibility Profile for Appearance of Postoperative Neuropathic Pain
An observational study of Pain, Postoperative, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Recent advances in the field of pain psychophysics that have enhanced the understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2005to Dec 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases. Exclusion Criteria: * Psychiatric or cognitive dysfunction precluding use of psychophysics * Existing thoracic pain * Patients who cannot communicate in Hebrew
Who may be able to join
- Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases.
Who cannot join
- Psychiatric or cognitive dysfunction precluding use of psychophysics
- Existing thoracic pain
- Patients who cannot communicate in Hebrew
Trial locations and contacts
1 site in 1 country.
About this study
Recent advances in the field of pain psychophysics that have enhanced the understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.
In this project, the researchers propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, the researchers expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The expected results of this project will serve the field of pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain.
Read the detailed description
The common prevalence of painful syndromes following surgical interventions and injuries calls for a preventive therapeutic approach that can only be based on better insight into the pain modulation mechanisms in these patients. Recent advances in the field of pain psychophysics that have enhanced our understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.
In this project, we propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Tests will include:
- psychophysical tests: pain thresholds and suprathreshold magnitude estimation, temporal summation, endogenous analgesia - diffuse noxious inhibitory control (DNIC);
- tests for the interaction between pain and the autonomic nervous system including the inhibitory effect of vagal activation on pain perception, and the response pattern of the sympatho-parasympathetic balance to noxious stimulation; and
- evaluation of personality components known to be associated with chronic pain including anxiety, catastrophization and somatization.
Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, we expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The contribution of the above tests to the severity of acute postoperative pain, and of the latter on the development of the chronic postoperative pain will also be evaluated.
The expected results of this project will serve pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain. Also, in the wider pain research context, this understanding will allow better design and analysis of studies on pain mechanisms and therapies by considering the pain susceptibility of participating patients.
- Conditions
- Pain, Postoperative
- Keywords
- thoracotomy, post-operative pain, chronic pain, endogenous analgesia, temporal summation, central sensitization, prediction, Patients Who Should Undergo Thoracotomy
- Medical subject headings
- Pain, Postoperative, Chronic Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Scientific Foundation
- Responsible party
- Principal investigator, d_yarnitsky, Rambam Health Care Campus
- Investigators
- David Yarnitsky, Professor, Principal investigator, Neurology Department Chairman, Rambam Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305136
- Sponsor's protocol ID
- Thoracotomy02CTIL
- Other IDs
- ISF
- Status last verified
- Oct 2017
- First submitted
- 19 Mar 2006
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancement of Psychophysics of Pain Modulation From Lab to Clinic: Constructing Susceptibility Profile for Appearance of Postoperative Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00305136
- Acronym / sponsor ID
- Thoracotomy02CTIL
- Conditions
- Pain, Postoperative
- Keywords
- thoracotomy, post-operative pain, chronic pain, endogenous analgesia, temporal summation, central sensitization, prediction, Patients Who Should Undergo Thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Israel Scientific Foundation
- Study start
- Dec 2005 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Mar 2006 (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.
Recent advances in the field of pain psychophysics that have enhanced the understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.
In this project, the researchers propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, the researchers expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The expected results of this project will serve the field of pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain.
Detailed description
The common prevalence of painful syndromes following surgical interventions and injuries calls for a preventive therapeutic approach that can only be based on better insight into the pain modulation mechanisms in these patients. Recent advances in the field of pain psychophysics that have enhanced our understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.
In this project, we propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Tests will include:
- psychophysical tests: pain thresholds and suprathreshold magnitude estimation, temporal summation, endogenous analgesia - diffuse noxious inhibitory control (DNIC);
- tests for the interaction between pain and the autonomic nervous system including the inhibitory effect of vagal activation on pain perception, and the response pattern of the sympatho-parasympathetic balance to noxious stimulation; and
- evaluation of personality components known to be associated with chronic pain including anxiety, catastrophization and somatization.
Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, we expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The contribution of the above tests to the severity of acute postoperative pain, and of the latter on the development of the chronic postoperative pain will also be evaluated.
The expected results of this project will serve pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain. Also, in the wider pain research context, this understanding will allow better design and analysis of studies on pain mechanisms and therapies by considering the pain susceptibility of participating patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases. Exclusion Criteria: * Psychiatric or cognitive dysfunction precluding use of psychophysics * Existing thoracic pain * Patients who cannot communicate in Hebrew
Key inclusion criteria (1 listed)
- Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases.
Key exclusion criteria (3 listed)
- Psychiatric or cognitive dysfunction precluding use of psychophysics
- Existing thoracic pain
- Patients who cannot communicate in Hebrew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Oct 2017.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
David Yarnitsky, Professor principal investigator
Neurology Department Chairman, Rambam Medical Center, Haifa, Israel
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 Pain, Postoperative, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 3 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 11 Oct 2017. 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 Israel. 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.
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 11 Oct 2017.