- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307471
Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism (NITT)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria :
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of spontaneous pain on the operated hemithorax
Time Frame: Day 0 (day of surgery)
|
Patient interview (yes/no)
|
Day 0 (day of surgery)
|
Presence of spontaneous pain on the operated hemithorax
Time Frame: Visit 2 = 2 months after Day 0 (day of surgery)
|
Patient interview (yes/no)
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Presence of spontaneous pain on the unoperated hemithorax
Time Frame: Day 0 (day of surgery)
|
Patient interview (yes/no)
|
Day 0 (day of surgery)
|
Presence of spontaneous pain on the unoperated hemithorax
Time Frame: Visit 2 = 2 months after Day 0 (day of surgery)
|
Patient interview (yes/no)
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Intensity of spontaneous pain on the operated hemithorax
Time Frame: Day 0 (day of surgery)
|
Numeric scale of value (from 0 to 10)
|
Day 0 (day of surgery)
|
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)
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Intensity of spontaneous pain on the unoperated hemithorax
Time Frame: Day 0 (day of surgery)
|
Numeric scale of value (from 0 to 10)
|
Day 0 (day of surgery)
|
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)
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Characteristics of spontaneous pain on the operated hemithorax
Time Frame: Day 0 (day of surgery)
|
Neuropathic Pain Symptom Inventory (NPSI) survey
|
Day 0 (day of surgery)
|
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
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Characteristics of spontaneous pain on the unoperated hemithorax
Time Frame: Day 0 (day of surgery)
|
Neuropathic Pain Symptom Inventory (NPSI) survey
|
Day 0 (day of surgery)
|
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
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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
|
Day 0 (day of surgery)
|
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
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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).
|
Day 0 (day of surgery)
|
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).
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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).
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
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.
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total or partial pneumonectomy
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Operated side
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Number of drains
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Location of drains
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Importance of rib spacing
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Realization of perioperative epidural anesthesia
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Realization of thoracic paravertebral block
Time Frame: Day 0 (day of surgery)
|
Operative report
|
Day 0 (day of surgery)
|
Realization of intercostal block
Time Frame: Day 0 (day of surgery)
|
Operative report
|
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)
|
Numeric scale of value (from 0 to 10)
|
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)
|
Numeric scale of value (from 0 to 10)
|
Visit 2 = 2 months after Day 0 (day of surgery)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHU-0161
- 2012-A00905-38 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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