Clinical trial NCT05307471: Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism
Official title: Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism Clinical, Psychophysical, Electrophysiological Approach, and in Response to Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thoracotomy
Thoracoscopy
Keywords: Thoracotomy
Thoracoscopy
Neuropathy
Neuropathic pain
Pulmonary surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing thoracotomy or thoracoscopy for partial or total lung resection

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.

Detailed description: Exploratory study, including additional examinations and visits. Biomedical research.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of spontaneous pain on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Presence of spontaneous pain on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Presence of spontaneous pain on the unoperated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Presence of spontaneous pain on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Intensity of spontaneous pain on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Intensity of spontaneous pain on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Intensity of spontaneous pain on the unoperated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Intensity of spontaneous pain on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Characteristics of spontaneous pain on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Characteristics of spontaneous pain on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Characteristics of spontaneous pain on the unoperated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Characteristics of spontaneous pain on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to cold on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to cold on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to cold on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to hot on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to hot on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold sensitivity to hot on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to cold on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to cold on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to hot on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of nociceptive threshold sensitivity to hot on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold tactile sensitivity on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of threshold tactile sensitivity on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of threshold tactile sensitivity on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of pressure pain threshold on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of pressure pain threshold on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of pressure pain threshold on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of the vibration sensitivity threshold on the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Measurement of the vibration sensitivity threshold on the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of the vibration sensitivity threshold on the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Thermographic photo of the operated hemithorax
timeFrame: Day 0 (day of surgery)
measure: Thermographic photo of the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Thermographic photo of the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of the conduction velocity in the operated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Measurement of the conduction velocity in the unoperated hemithorax
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
Secondary outcomes:
measure: Total or partial pneumonectomy
timeFrame: Day 0 (day of surgery)
measure: Operated side
timeFrame: Day 0 (day of surgery)
measure: Number of drains
timeFrame: Day 0 (day of surgery)
measure: Location of drains
timeFrame: Day 0 (day of surgery)
measure: Importance of rib spacing
timeFrame: Day 0 (day of surgery)
measure: Realization of perioperative epidural anesthesia
timeFrame: Day 0 (day of surgery)
measure: Realization of thoracic paravertebral block
timeFrame: Day 0 (day of surgery)
measure: Realization of intercostal block
timeFrame: Day 0 (day of surgery)
measure: Response induced analgesia with topical lidocaine (in case of persistant pain)
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
measure: Response induced analgesia to pregabalin (in case of persistent pain)
timeFrame: Visit 2 = 2 months after Day 0 (day of surgery)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Christian DUALE
role: PRINCIPAL_INVESTIGATOR
References: