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.

Yeung, Joyce, Middleton, Lee, Tryposkiadis, Kostas, Kerr, Amy, Daniels, 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 (7). e023679. ISSN 2044-6055. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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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.

TRIAL REGISTRATION NUMBER

ISRCTN45041624.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: WO Surgery
WO Surgery > WO500 Anaesthesia
Divisions: Planned IP Care > Thoracic Surgery
Related URLs:
Depositing User: Jamie Edgar
Date Deposited: 14 Aug 2020 13:48
Last Modified: 14 Aug 2020 13:48
URI: http://www.repository.uhblibrary.co.uk/id/eprint/3362

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