Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism (NITT)

University Hospital, Clermont-Ferrand

Status: Terminated

Conditions: Thoracoscopy; Thoracotomy

Treatments: Other: Thoracotomy/scopy

Study type: Observational

Funder types: Other

Identifiers

NCT05307471

2012-A00905-38 (Other Identifier)

CHU-0161

Details and patient eligibility

About

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.

Full description

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

34 participants in 1 patient group

neuropathic pain

Description:

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

Treatment:

Other: Thoracotomy/scopy