ThoracotomyNITTNCT05307471
Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism
An observational study of Thoracotomy and Thoracoscopy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Pulmonary surgery, performed routinely by thoracotomy or thoracoscopy, can cause significant and frequent chronic postoperative pain, most often neuropathic. The role of trauma intraoperative intercostal nerve is evoked to explain the genesis of the neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracotomy, Thoracoscopy
- What is being tested?
- Thoracotomy/scopy
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2013to 15 Nov 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing thoracotomy or thoracoscopy for partial or total lung resection
Who may be able to join
- patients undergoing lateral or posterolateral thoracotomy scheduled lung surgery, regardless of indication, or lung or pleural scheduled surgery (treatment of recurrent pneumothorax) by thoracoscopy;
- 18 to 80 years
- Informed consent to the trial
- Protected by the French health welfare
Who cannot join
- Refusal of the patient;
- Preexisting neuropathy ;
- Treatment of active substance known on neuropathic pain: gabapentin, pregabalin, amitryptyline, duloxetine, venlafaxine, tricyclic antidepressants, topical lidocaine or capsaicin;
- Emergency surgery;
- Specific clinical contexts including terminal or palliative neoplasia;
- Deficit psychiatric pathology and dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism Clinical, Psychophysical, Electrophysiological Approach, and in Response to Therapy
Pulmonary surgery, performed routinely by thoracotomy or thoracoscopy, can cause significant and frequent chronic postoperative pain, most often neuropathic. The role of trauma intraoperative intercostal nerve is evoked to explain the genesis of the neuropathy. Treatments proposed in the indication of neuropathic pain in a broad sense, are exposed to many cases of failures. It is supposed that these failures are due to a mismatch between the selected drug (which is specific to the target) and the real pathology because neuropathy encompasses many different pathophysiological syndromes which are sometimes intricated.
The main objective of this project is to study the clinical, psychophysical and electrophysiological (noninvasively) intercostal nerve affected by the surgery at the second postoperative month, by comparing the results with similar observations made shortly before the intervention.
Read more
This study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin, the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion.
The other objective of the project is to provide a treatment algorithm for patients in pain, and to compare the efficacy of this treatment with the pre-treatment observations data.
Read the detailed description
Exploratory study, including additional examinations and visits. Biomedical research.
- Conditions
- Thoracotomy, Thoracoscopy
- Being tested
- Thoracotomy/scopy
- Keywords
- Thoracotomy, Thoracoscopy, Neuropathy, Neuropathic pain, Pulmonary surgery
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracotomy/scopyOther
| Study group | Role | What they receive |
|---|---|---|
| neuropathic pain | This study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin (Prof. M. Filaire), the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion Receives: Other: Thoracotomy/scopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of spontaneous pain on the operated hemithorax
Patient interview (yes/no)
Measured: Day 0 (day of surgery)
Presence of spontaneous pain on the operated hemithorax
Patient interview (yes/no)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Presence of spontaneous pain on the unoperated hemithorax
Patient interview (yes/no)
Measured: Day 0 (day of surgery)
Presence of spontaneous pain on the unoperated hemithorax
Patient interview (yes/no)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Intensity of spontaneous pain on the operated hemithorax
Numeric scale of value (from 0 to 10)
Measured: Day 0 (day of surgery)
Intensity of spontaneous pain on the operated hemithorax
Numeric scale of value (from 0 to 10)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Intensity of spontaneous pain on the unoperated hemithorax
Numeric scale of value (from 0 to 10)
Measured: Day 0 (day of surgery)
Intensity of spontaneous pain on the unoperated hemithorax
Numeric scale of value (from 0 to 10)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Characteristics of spontaneous pain on the operated hemithorax
Neuropathic Pain Symptom Inventory (NPSI) survey
Measured: Day 0 (day of surgery)
Characteristics of spontaneous pain on the operated hemithorax
Neuropathic Pain Symptom Inventory (NPSI) survey
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Characteristics of spontaneous pain on the unoperated hemithorax
Neuropathic Pain Symptom Inventory (NPSI) survey
Measured: Day 0 (day of surgery)
Characteristics of spontaneous pain on the unoperated hemithorax
Neuropathic Pain Symptom Inventory (NPSI) survey
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold sensitivity to cold on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Day 0 (day of surgery)
Measurement of threshold sensitivity to cold on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold sensitivity to cold on the unoperated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold sensitivity to hot on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Day 0 (day of surgery)
Measurement of threshold sensitivity to hot on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold sensitivity to hot on the unoperated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to cold on the unoperated hemithorax
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of nociceptive threshold sensitivity to hot on the unoperated hemithorax
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold tactile sensitivity on the operated hemithorax
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measured: Day 0 (day of surgery)
Measurement of threshold tactile sensitivity on the operated hemithorax
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of threshold tactile sensitivity on the unoperated hemithorax
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of pressure pain threshold on the operated hemithorax
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measured: Day 0 (day of surgery)
Measurement of pressure pain threshold on the operated hemithorax
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of pressure pain threshold on the unoperated hemithorax
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of the vibration sensitivity threshold on the operated hemithorax
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Measured: Day 0 (day of surgery)
Measurement of the vibration sensitivity threshold on the operated hemithorax
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of the vibration sensitivity threshold on the unoperated hemithorax
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Thermographic photo of the operated hemithorax
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Measured: Day 0 (day of surgery)
Thermographic photo of the operated hemithorax
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Thermographic photo of the unoperated hemithorax
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of the conduction velocity in the operated hemithorax
A peripheral stimulation will be performed using a technique used in the intercostal region, and a cervical signal will be collected.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Measurement of the conduction velocity in the unoperated hemithorax
A peripheral stimulation will be performed using a technique used in the intercostal region, and a cervical signal will be collected.
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Secondary outcomes (10)
Total or partial pneumonectomy
Operative report
Measured: Day 0 (day of surgery)
Operated side
Operative report
Measured: Day 0 (day of surgery)
Number of drains
Operative report
Measured: Day 0 (day of surgery)
Location of drains
Operative report
Measured: Day 0 (day of surgery)
Importance of rib spacing
Operative report
Measured: Day 0 (day of surgery)
Realization of perioperative epidural anesthesia
Operative report
Measured: Day 0 (day of surgery)
Realization of thoracic paravertebral block
Operative report
Measured: Day 0 (day of surgery)
Realization of intercostal block
Operative report
Measured: Day 0 (day of surgery)
Response induced analgesia with topical lidocaine (in case of persistant pain)
Numeric scale of value (from 0 to 10)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Response induced analgesia to pregabalin (in case of persistent pain)
Numeric scale of value (from 0 to 10)
Measured: Visit 2 = 2 months after Day 0 (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start28 Oct 2013
- Primary completion12 Apr 2017
- Study completion15 Nov 2021
Why it stopped: No neuropathic pain in recruited subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian DUALE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307471
- Sponsor's protocol ID
- CHU-0161
- Other IDs
- 2012-A00905-38
- Acronym
- NITT
- Status last verified
- Nov 2021
- First submitted
- 25 Jun 2013
- Last updated
- 1 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism Clinical, Psychophysical, Electrophysiological Approach, and in Response to Therapy
- ClinicalTrials.gov ID
- NCT05307471
- Acronym / sponsor ID
- NITT / CHU-0161
- Conditions
- Thoracotomy, Thoracoscopy
- Keywords
- Thoracotomy, Thoracoscopy, Neuropathy, Neuropathic pain, Pulmonary surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No neuropathic pain in recruited subjects
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 1 Apr 2022 (actual)
- 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.
Pulmonary surgery, performed routinely by thoracotomy or thoracoscopy, can cause significant and frequent chronic postoperative pain, most often neuropathic. The role of trauma intraoperative intercostal nerve is evoked to explain the genesis of the neuropathy. Treatments proposed in the indication of neuropathic pain in a broad sense, are exposed to many cases of failures. It is supposed that these failures are due to a mismatch between the selected drug (which is specific to the target) and the real pathology because neuropathy encompasses many different pathophysiological syndromes which are sometimes intricated.
The main objective of this project is to study the clinical, psychophysical and electrophysiological (noninvasively) intercostal nerve affected by the surgery at the second postoperative month, by comparing the results with similar observations made shortly before the intervention.
This study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin, the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion.
The other objective of the project is to provide a treatment algorithm for patients in pain, and to compare the efficacy of this treatment with the pre-treatment observations data.
Detailed description
Exploratory study, including additional examinations and visits. Biomedical research.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuropathic pain | – | Other: Thoracotomy/scopyThis study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin (Prof. M. Filaire), the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing thoracotomy or thoracoscopy for partial or total lung resection
Key inclusion criteria (4 listed)
- patients undergoing lateral or posterolateral thoracotomy scheduled lung surgery, regardless of indication, or lung or pleural scheduled surgery (treatment of recurrent pneumothorax) by thoracoscopy;
- 18 to 80 years
- Informed consent to the trial
- Protected by the French health welfare
Key exclusion criteria (6 listed)
- Refusal of the patient;
- Preexisting neuropathy ;
- Treatment of active substance known on neuropathic pain: gabapentin, pregabalin, amitryptyline, duloxetine, venlafaxine, tricyclic antidepressants, topical lidocaine or capsaicin;
- Emergency surgery;
- Specific clinical contexts including terminal or palliative neoplasia;
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 |
|---|---|---|
| Thoracotomy/scopy | Other | neuropathic pain |
Primary outcome
Presence of spontaneous pain on the operated hemithorax
Time frame: Day 0 (day of surgery)
Patient interview (yes/no)
Presence of spontaneous pain on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Patient interview (yes/no)
Presence of spontaneous pain on the unoperated hemithorax
Time frame: Day 0 (day of surgery)
Patient interview (yes/no)
Presence of spontaneous pain on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Patient interview (yes/no)
Intensity of spontaneous pain on the operated hemithorax
Time frame: Day 0 (day of surgery)
Numeric scale of value (from 0 to 10)
Intensity of spontaneous pain on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Numeric scale of value (from 0 to 10)
Intensity of spontaneous pain on the unoperated hemithorax
Time frame: Day 0 (day of surgery)
Numeric scale of value (from 0 to 10)
Intensity of spontaneous pain on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Numeric scale of value (from 0 to 10)
Characteristics of spontaneous pain on the operated hemithorax
Time frame: Day 0 (day of surgery)
Neuropathic Pain Symptom Inventory (NPSI) survey
Characteristics of spontaneous pain on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Neuropathic Pain Symptom Inventory (NPSI) survey
Characteristics of spontaneous pain on the unoperated hemithorax
Time frame: Day 0 (day of surgery)
Neuropathic Pain Symptom Inventory (NPSI) survey
Characteristics of spontaneous pain on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Neuropathic Pain Symptom Inventory (NPSI) survey
Measurement of threshold sensitivity to cold on the operated hemithorax
Time frame: Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of threshold sensitivity to cold on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of threshold sensitivity to cold on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of threshold sensitivity to hot on the operated hemithorax
Time frame: Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of threshold sensitivity to hot on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of threshold sensitivity to hot on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot sensation will be first perceived, thus defining the thermal threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
Time frame: Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to cold on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a cold painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
Time frame: Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of nociceptive threshold sensitivity to hot on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
The thermode will be applied and patients will be asked to press a button when a hot painful sensation will be first perceived, thus defining the thermal nociceptive threshold for that stimulus presentation.
Measurement of threshold tactile sensitivity on the operated hemithorax
Time frame: Day 0 (day of surgery)
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measurement of threshold tactile sensitivity on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measurement of threshold tactile sensitivity on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Thickness of the 1st filament felt by the patient by application of Von Frey filaments of increasing size from 0.008 to 300 grams in pressure equivalent
Measurement of pressure pain threshold on the operated hemithorax
Time frame: Day 0 (day of surgery)
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measurement of pressure pain threshold on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measurement of pressure pain threshold on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
An algogenic tip is applied with increasing pressure measured in grams checked on the monitor's digital screen. The subject will be educated to signal by applying a button (sound signal) when the required sensation (beginning pain) is reached.
Measurement of the vibration sensitivity threshold on the operated hemithorax
Time frame: Day 0 (day of surgery)
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Measurement of the vibration sensitivity threshold on the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Measurement of the vibration sensitivity threshold on the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
As soon as the subject perceives the vibration of the vibrameter, the value displayed on the digital panel will be noted. The operator will then increase the intensity a little then go back down. As soon as the patient no longer feels the vibration, the value displayed on the digital panel will be noted. The vibration perception value is obtained by calculating the average of the high and low values obtained.
Thermographic photo of the operated hemithorax
Time frame: Day 0 (day of surgery)
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Thermographic photo of the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Thermographic photo of the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
A camera coupled with a software makes it possible to identify changes in skin temperature. The region(s) clinically identified as pathological (neuropathic) will be identified beforehand by cutaneous tags (adhesive metallic controls that have been cooled beforehand).
Measurement of the conduction velocity in the operated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
A peripheral stimulation will be performed using a technique used in the intercostal region, and a cervical signal will be collected.
Measurement of the conduction velocity in the unoperated hemithorax
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
A peripheral stimulation will be performed using a technique used in the intercostal region, and a cervical signal will be collected.
10 secondary outcomes
Total or partial pneumonectomy
Time frame: Day 0 (day of surgery)
Operated side
Time frame: Day 0 (day of surgery)
Number of drains
Time frame: Day 0 (day of surgery)
Location of drains
Time frame: Day 0 (day of surgery)
Importance of rib spacing
Time frame: Day 0 (day of surgery)
Realization of perioperative epidural anesthesia
Time frame: Day 0 (day of surgery)
Realization of thoracic paravertebral block
Time frame: Day 0 (day of surgery)
Realization of intercostal block
Time frame: Day 0 (day of surgery)
Response induced analgesia with topical lidocaine (in case of persistant pain)
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Response induced analgesia to pregabalin (in case of persistent pain)
Time frame: Visit 2 = 2 months after Day 0 (day of surgery)
Results and safety
The study was stopped early (reason given: No neuropathic pain in recruited subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Related trials for Thoracotomy
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingObservational study
Preoperative Nutritional Status and Postoperative Outcomes in Geriatric Lung Resection
Thoracotomy, Toracosurgery
RecruitingObservational study
Continuous Erector Spinae Block Versus Thoracic Epidural Analgesia for the Prevention of Chronic Pain Following Thoracotomy: a Retrospective Study
Thoracic Surgery
Not yet recruiting
The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
Thoracostomy Pain Management, Pain Management
Active, not recruiting
Postoperative Opioid Consumption of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Paravertebral Block
Opioid Consumption, Postoperative
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.
Christian DUALE principal investigator
University Hospital, Clermont-Ferrand
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 Thoracotomy and Thoracoscopy, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 6 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 1 Apr 2022. 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 was stopped early (reason given: No neuropathic pain in recruited subjects). 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?
Presence of spontaneous pain on the operated hemithorax (time frame: Day 0 (day of surgery)). The study lists 38 primary outcomes in all. 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 1 Apr 2022.