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Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC) : a pilot study to assess feasibility of a large multicentre trial
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Yeung, Joyce, Middleton, Lee, Tryposkiadis, Kostas, Kerr, Amy, Daniel, Jane, Naidu, Babu, Melody, Teresa, Goebel, Andreas, Wilson, Matthew, Kumar, Sajith, Szentgyorgyi, Lajos, Flanagan, Sarah, Shah, Rajesh, Worrall, Antony and Gao, Fang (2019) Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC) : a pilot study to assess feasibility of a large multicentre trial. BMJ Open, 9 . e023679. doi:10.1136/bmjopen-2018-023679
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WRAP-randomised-controlled-trial-thoracic-epidural-chronic-pain-Yeung-2019.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (424Kb) | Preview |
Official URL: https://doi.org/10.1136/bmjopen-2018-023679
Abstract
Objectives Thoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB.
Design A randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible.
Setting Two adult thoracic centres in the UK.
Participants All adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy.
Results All patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns.
Conclusions A large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably.
| Item Type: | Journal Article | |||||||||
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| Subjects: | R Medicine > RD Surgery R Medicine > RZ Other systems of medicine |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Analgesia, Chest -- Surgery, Chronic pain -- Treatment, Critical care medicine -- Evaluation | |||||||||
| Journal or Publication Title: | BMJ Open | |||||||||
| Publisher: | BMJ | |||||||||
| ISSN: | 2044-6055 | |||||||||
| Official Date: | 9 July 2019 | |||||||||
| Dates: |
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| Date of first compliant deposit: | 10 February 2020 | |||||||||
| Volume: | 9 | |||||||||
| Article Number: | e023679 | |||||||||
| DOI: | 10.1136/bmjopen-2018-023679 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access | |||||||||
| RIOXX Funder/Project Grant: |
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