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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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; Gao, Fang.

In: BMJ open, Vol. 9, No. 7, e023679, 09.07.2019.

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@article{ec8a6583cb1349e4aa4324c9dbf42544,
title = "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",
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.",
keywords = "adult anaesthesia, clinical trials, pain management, thoracic surgery",
author = "Joyce Yeung and Lee Middleton and Kostas Tryposkiadis and Amy Kerr and Jane Daniels and Babu Naidu and Teresa Melody and Andreas Goebel and Matthew Wilson and Sajith Kumar and Lajos Szentgyorgyi and Sarah Flanagan and Rajesh Shah and Antony Worrall and Fang Gao",
note = "{\circledC} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.",
year = "2019",
month = "7",
day = "9",
doi = "10.1136/bmjopen-2018-023679",
language = "English",
volume = "9",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "7",

}

RIS

TY - JOUR

T1 - Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC)

T2 - a pilot study to assess feasibility of a large multicentre trial

AU - Yeung, Joyce

AU - Middleton, Lee

AU - Tryposkiadis, Kostas

AU - Kerr, Amy

AU - Daniels, Jane

AU - Naidu, Babu

AU - Melody, Teresa

AU - Goebel, Andreas

AU - Wilson, Matthew

AU - Kumar, Sajith

AU - Szentgyorgyi, Lajos

AU - Flanagan, Sarah

AU - Shah, Rajesh

AU - Worrall, Antony

AU - Gao, Fang

N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

PY - 2019/7/9

Y1 - 2019/7/9

N2 - 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.

AB - 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.

KW - adult anaesthesia

KW - clinical trials

KW - pain management

KW - thoracic surgery

UR - http://www.scopus.com/inward/record.url?scp=85068878297&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2018-023679

DO - 10.1136/bmjopen-2018-023679

M3 - Article

C2 - 31292172

VL - 9

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 7

M1 - e023679

ER -