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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 ISSN 2044-6055.

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Official URL: https://doi.org/10.1136/bmjopen-2018-023679

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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
Subjects: R Medicine > RD Surgery
R Medicine > RZ Other systems of medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
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:
DateEvent
9 July 2019Published
31 January 2019Accepted
Volume: 9
Article Number: e023679
DOI: 10.1136/bmjopen-2018-023679
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 10 February 2020
Date of first compliant Open Access: 10 February 2020
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
PB-PG-0213-30126[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDNational Institute for Health Research (Great Britain). Collaboration for Leadership in Applied Health Research and Care West MidlandsUNSPECIFIED

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