Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)
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Le résumé fourni par la source
BACKGROUND: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain. METHODS: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as 'worst chest pain over the last week' equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis. DISCUSSION: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS. TRIAL REGISTRATION: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856 . First patient recruited 8 January 2019.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)
- Date Crossref
- 23/11/2023
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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University of Glasgow pays non établi dans la noticeUniversité ou école supérieure
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University of Liverpool Institute of Translational Medicine pays non établi dans la noticeUniversité ou école supérieure
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University of Birmingham Health Economics Unit pays non établi dans la noticeUniversité ou école supérieure
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Cancer Research UK Clinical Trials Unit pays non établi dans la noticeStructure de recherche
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University of Bristol Population Health Sciences pays non établi dans la noticeUniversité ou école supérieure
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NIHR Surgical Reconstruction and Microbiology Research Centre pays non établi dans la noticeStructure de recherche
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Imperial College London Department of Surgery and Cancer pays non établi dans la noticeUniversité ou école supérieure
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Manchester University NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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University of Sheffield pays non établi dans la noticeUniversité ou école supérieure
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University of Warwick Warwick Medical School pays non établi dans la noticeUniversité ou école supérieure
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School of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Birmingham Clinical Trial Unit pays non établi dans la noticeÉtablissement de santé
University of Glasgow, Institute of Translational Medicine — University of Liverpool et Health Economics Unit — University of Birmingham, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.