The clinical and cost-effectiveness of paravertebral blockade versus thoracic epidural blockade in reducing chronic post-thoracotomy pain: TOPIC2 RCT synopsis
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Résumé
Background: More than a third of patients undergoing thoracotomy suffer from debilitating chronic post-thoracotomy pain lasting months or years postoperatively. Aggressive management of acute pain during the perioperative period may mitigate this risk. Objective(s): To determine the clinical and cost-effectiveness of paravertebral blockade compared to thoracic epidural blockade, by testing the hypothesis that paravertebral blockade reduces the incidence of chronic post-thoracotomy pain. Design and methods: A parallel, open, multicentre, randomised controlled with integrated health-economic evaluation and an internal pilot that incorporated a qualitative recruitment intervention. Setting and participants: Adult patients undergoing thoracotomy in 15 United Kingdom centres. Interventions: Paravertebral blockade compared to thoracic epidural blockade. Main outcome measures: The primary outcome was the presence of chronic post-thoracotomy pain at 6 months post randomisation defined as 'worst chest pain over the last week' of at least moderate intensity, with a visual analogue scale score ≥ 40 mm. Secondary outcomes included visual analogue scale pain scores in the acute (days 1, 2, 3 and discharge) and chronic (3, 6 and 12 months) phases postoperatively; Brief Pain Inventory; Short Form McGill Pain Questionnaire 2; Hospital Anxiety and Depression Scale; patient satisfaction; analgesia use in the acute and chronic phases; complications (analgesic, surgical and pulmonary) and mortality. For the economic evaluation, the EuroQol-5 Dimensions, five-level version questionnaire was utilised. Results: = 0.12]. During the acute phase, both worst and average pain was higher on day 1 with paravertebral blockade [adjusted mean difference 7.7 mm (95% confidence interval 2.8 to 12.5) and 7.0 mm (95% confidence interval 2.7 to 11.2), respectively] but not different on days 2 and 3. Hypotension was less common in the paravertebral blockade group [adjusted risk ratio = 0.66 (95% confidence interval 0.46 to 0.94)], and overall complications were comparable between groups. The health-economic analysis demonstrated that thoracic epidural blockade produced an additional 0.04 quality-adjusted life-years when compared to paravertebral blockade, and was associated with slightly lower costs, but these differences were not statistically significant. Limitations: The main limitation is the reduced sample size from 1026 to 770, which reduced the associated power from 90% to 80%. The key reasons are related to practice change over time resulting in a downgrade in equipoise and the COVID pandemic. Also, we cannot rule out that lack of blinding may have had some impact on the acute phase outcomes. Conclusions: In our study, paravertebral blockade and thoracic epidural blockade appear to be equivalent in clinical and cost-effectiveness in preventing chronic post-thoracotomy at 6 months; this may be paving the way for both techniques likely to continue in National Health Service thoracic settings, based on clinician and patient's choices. Future work: Using full TOPIC-2 data sets, defined according to the European Society of Thoracic Surgeons data set, to explore the trajectory of the development from acute to chronic post-surgery pain. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/111/111.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle