Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism

Thoracotomy Clinical Trial

— NITT  

Official title:

Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism Clinical, Psychophysical, Electrophysiological Approach, and in Response to Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05307471
• Other study ID #: CHU-0161
• Secondary ID: 2012-A00905-38
• Status: Terminated
• Start date: October 28, 2013
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

Exploratory study, including additional examinations and visits. Biomedical research.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: November 15, 2021
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thoracoscopy
• Thoracotomy

Intervention

Other:
• Thoracotomy/scopy

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of spontaneous pain on the operated hemithorax	Patient interview (yes/no)	Day 0 (day of surgery)
Primary	Presence of spontaneous pain on the operated hemithorax	Patient interview (yes/no)	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	Presence of spontaneous pain on the unoperated hemithorax	Patient interview (yes/no)	Day 0 (day of surgery)
Primary	Presence of spontaneous pain on the unoperated hemithorax	Patient interview (yes/no)	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	Intensity of spontaneous pain on the operated hemithorax	Numeric scale of value (from 0 to 10)	Day 0 (day of surgery)
Primary	Intensity of spontaneous pain on the operated hemithorax	Numeric scale of value (from 0 to 10)	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	Intensity of spontaneous pain on the unoperated hemithorax	Numeric scale of value (from 0 to 10)	Day 0 (day of surgery)
Primary	Intensity of spontaneous pain on the unoperated hemithorax	Numeric scale of value (from 0 to 10)	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	Characteristics of spontaneous pain on the operated hemithorax	Neuropathic Pain Symptom Inventory (NPSI) survey	Day 0 (day of surgery)
Primary	Characteristics of spontaneous pain on the operated hemithorax	Neuropathic Pain Symptom Inventory (NPSI) survey	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	Characteristics of spontaneous pain on the unoperated hemithorax	Neuropathic Pain Symptom Inventory (NPSI) survey	Day 0 (day of surgery)
Primary	Characteristics of spontaneous pain on the unoperated hemithorax	Neuropathic Pain Symptom Inventory (NPSI) survey	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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	Day 0 (day of surgery)
Primary	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	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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).	Day 0 (day of surgery)
Primary	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).	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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).	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Primary	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.	Visit 2 = 2 months after Day 0 (day of surgery)
Secondary	Total or partial pneumonectomy	Operative report	Day 0 (day of surgery)
Secondary	Operated side	Operative report	Day 0 (day of surgery)
Secondary	Number of drains	Operative report	Day 0 (day of surgery)
Secondary	Location of drains	Operative report	Day 0 (day of surgery)
Secondary	Importance of rib spacing	Operative report	Day 0 (day of surgery)
Secondary	Realization of perioperative epidural anesthesia	Operative report	Day 0 (day of surgery)
Secondary	Realization of thoracic paravertebral block	Operative report	Day 0 (day of surgery)
Secondary	Realization of intercostal block	Operative report	Day 0 (day of surgery)
Secondary	Response induced analgesia with topical lidocaine (in case of persistant pain)	Numeric scale of value (from 0 to 10)	Visit 2 = 2 months after Day 0 (day of surgery)
Secondary	Response induced analgesia to pregabalin (in case of persistent pain)	Numeric scale of value (from 0 to 10)	Visit 2 = 2 months after Day 0 (day of surgery)