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Chronic postoperative pain (CPOP) after video-assisted thoracic surgery (VATS) is severe because it results from lesions at multiple levels: incisions, pulmonary or nerve contusions. PCOD is defined by the IASP (International Association for the Study of Pain) as persistent pain 3 months after surgery. It affects around 30% of patients and significantly impairs recovery and quality of life.
One of the many factors contributing to the appearance of PCOD is acute perioperative pain. To combat this acute pain and limit postoperative chronic pain, a multimodal analgesia strategy is necessary, particularly during thoracic surgery with a high nociceptive potential. This type of protocol will enable acute pain to be controlled by various means: tier 1 analgesics (paracetamol, NSAIDs), tier 2 (nefopam, tramadol) and tier 3 (opioid drugs), locoregional anaesthesia, co-analgesics and non-medicinal techniques. Thus, avoiding NSAIDs will have no effect on the increase in acute pain. A study of the impact of eliminating NSAIDs on chronic pain can therefore be carried out without increasing patients' acute pain.
A team from McGill University, Montreal, Canada, recently discovered a paradoxical effect of anti-inflammatory drugs on the chronicisation of pain. They demonstrated that although anti-inflammatory drugs initially had an acute analgesic effect, they induced neutrophil depletion and a drastic change in the transcriptome postoperatively, leading to more chronic pain. These studies highlight the fact that although NSAIDs have an acute analgesic effect, their use could ultimately prove counterproductive by encouraging the development of CD. However, to date there are no studies demonstrating that a minimum dose or duration of NSAID treatment leads to the development of DCPO. On the basis of these results, it is justified to assess the impact of NSAIDs widely used in routine care in thoracic surgery on the development of DCPO.
In order to improve pain management in the intraoperative phase, nociception monitoring is necessary. The PMD200® (Medasense Biometrics Ltd.) is the most recent monitor designed for this purpose, having demonstrated sensitivity and specificity in detecting nociceptive stimuli under general anaesthesia (4). It will make it possible to guide the administration of analgesic agents by displaying a nociception index (NOL index).
Our hypothesis, based on this work, is that anti-inflammatory drugs, despite having an acute analgesic effect, could promote the development of DCPO after VATS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AINS+ | Active Comparator |
|
|
| AINS- | Experimental | no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no NSAID | Drug | no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS) | 3 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Maximum Pain Scores at Rest and During Mobilisation Using a Numerical Rating Scale | Days 0, 1, 3, 1 month and 3 months post-op | |
| Assessment of Neuropathic Pain Using the DN4 Questionnaire | Days 1, 3, 1 month and 3 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walid OULEHRI | Contact | +33 3 69 55 12 71 | walid.oulehri@chru-strasbourg.fr |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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phase 3, double-blind, multicentre, placebo-controlled, randomised, parallel-arm trial
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| protocol for administering NSAIDs already used in routine care | Drug |
|
|
| Cumulative Morphine Equivalent Dose of Opioids Administered Intraoperatively | Days 1, 3, 1 month and 3 months post-op |
| Length of Hospital Stay in Both Patient Groups | up to 3 months post-op |
| QoR-15 Score | 1 month and 3 months post-op |
| Collection of Adverse Events and Serious Adverse Events | up to 3 months post-op |
| Global Proteomic and Transcriptomic (RNA-seq) Analysis and Targeted RT-qPCR of Blood Samples | Days 1, 3 and 3 months post-op |
| Blood tests for Complete Blood Count by cytometry | Erythrocytes, leukocytes, thrombocytes and associated indices (haemoglobin, haematocrit, etc.) | Days 0, 1, and 3 months post-op |
| SF-36 Score | 1 month and 3 months post-op |
| Physical and Mental Component Scores | 1 month and 3 months post-op |
| Inflammatory Marker Assessment Including Interleukins | Days 0, 1, and 3 months post-op |
| Blood tests for C-reactive protein by immunoassay | The results are expressed in mg/L (milligrams per litre) | Days 0, 1, and 3 months post-op |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |