Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism

NCT ID: NCT05307471

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-28

Study Completion Date

2021-11-15

Brief Summary

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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

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

Conditions

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Thoracotomy Thoracoscopy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Thoracotomy/scopy

Intervention Type OTHER

Interventions

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Thoracotomy/scopy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian DUALE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00905-38

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0161

Identifier Type: -

Identifier Source: org_study_id

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