Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism

NCT05307471 | Terminated

• 2 other identifiers: CHU-01612012-A00905-38
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracotomy; Thoracoscopy

Keywords

Thoracotomy; Thoracoscopy; Neuropathy; Neuropathic pain; Pulmonary surgery

Outcome Measures

Primary Outcomes (38)

• Presence of spontaneous pain on the operated hemithorax

  Patient interview (yes/no)

  Day 0 (day of surgery)

• Presence of spontaneous pain on the operated hemithorax

  Patient interview (yes/no)

  Visit 2 = 2 months after Day 0 (day of surgery)

• Presence of spontaneous pain on the unoperated hemithorax

  Patient interview (yes/no)

  Day 0 (day of surgery)

• Presence of spontaneous pain on the unoperated hemithorax

  Patient interview (yes/no)

  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)

  Day 0 (day of surgery)

• 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)

• Intensity of spontaneous pain on the unoperated hemithorax

  Numeric scale of value (from 0 to 10)

  Day 0 (day of surgery)

• 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)

• Characteristics of spontaneous pain on the operated hemithorax

  Neuropathic Pain Symptom Inventory (NPSI) survey

  Day 0 (day of surgery)

• Characteristics of spontaneous pain on the operated hemithorax

  Neuropathic Pain Symptom Inventory (NPSI) survey

  Visit 2 = 2 months after Day 0 (day of surgery)

• Characteristics of spontaneous pain on the unoperated hemithorax

  Neuropathic Pain Symptom Inventory (NPSI) survey

  Day 0 (day of surgery)

• Characteristics of spontaneous pain on the unoperated hemithorax

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (10)

• Total or partial pneumonectomy

  Day 0 (day of surgery)

• Operated side

  Day 0 (day of surgery)

• Number of drains

  Day 0 (day of surgery)

• Location of drains

  Day 0 (day of surgery)

• Importance of rib spacing

  Day 0 (day of surgery)

Study Arms (1)

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

Other: Thoracotomy/scopy

Interventions

Thoracotomy/scopy OTHER

neuropathic pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing thoracotomy or thoracoscopy for partial or total lung resection

You may qualify if:

• patients undergoing lateral or posterolateral thoracotomy scheduled lung surgery, regardless of indication, or lung or pleural scheduled surgery (treatment of recurrent pneumothorax) by thoracoscopy;
• to 80 years
• Informed consent to the trial
• Protected by the French health welfare

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Christian DUALE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: April 1, 2022
• Study Start: October 28, 2013
• Primary Completion: April 12, 2017
• Study Completion: November 15, 2021
• Last Updated: April 1, 2022

Record last verified: 2021-11

Locations

FR (1)