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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
  1. Joyce Yeung1,2,
  2. Lee Middleton3,
  3. Kostas Tryposkiadis4,
  4. Amy Kerr5,
  5. Jane Daniels6,
  6. Babu Naidu5,7,
  7. Teresa Melody2,
  8. Andreas Goebel8,
  9. Matthew Wilson9,
  10. Sajith Kumar2,
  11. Lajos Szentgyorgyi10,
  12. Sarah Flanagan11,
  13. Rajesh Shah12,
  14. Antony Worrall2,
  15. Fang Gao2,7
  1. 1Warwick Medical School, University of Warwick, Coventry, UK
  2. 2Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK
  3. 3School of Health and Population Sciences, University of Birmingham, Birmingham, UK
  4. 4Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
  5. 5Department of Thoracic Surgery, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK
  6. 6Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
  7. 7Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  8. 8University of Liverpool, Institute of Translational Medicine, Liverpool, UK
  9. 9Health Services Research, University of Sheffield, Sheffield, UK
  10. 10Department of Anaesthesia, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
  11. 11Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  12. 12Department of Thoracic Surgery, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
  1. Correspondence to Professor Fang Gao; f.gaosmith{at}bham.ac.uk

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

  • pain management
  • adult anaesthesia
  • thoracic surgery
  • clinical trials

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors FG, JY, JD and MW conceived the topic. FG, JY, JD, LM and AG designed the study with input from SK, LS, BN, MW, TM and AW. FG oversaw the running of the trial and all the authors contributed to the ongoing management of the trial. AK, RS and BN collected data for the trial. KT performed the statistical analysis. SF evaluated the qualitative data. The manuscript was drafted by LM, JY and FG with contributions from the other authors. All the authors contributed to the interpretation of the output and revised and reviewed the paper; they are the guarantors. The Birmingham Clinical Trials Unit undertook the randomisation and data management and monitoring. The authors had full access to all the data from the study. The authors vouch for the accuracy and completeness of the data and analyses. All authors read and approved the final manuscript.

  • Funding The study was funded by a grant from the National Institute for Health Research for Patient Benefit (RFPB grant number PB-PG-0213-30126). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. SF is funded by the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care West Midlands (CLAHRCWM). The study sponsor was the Heart of England NHS Foundation Trust.

  • Disclaimer The funder had no role in study design, data collection, interpretation or analysis or in writing the report for publication.

  • Competing interests None declared.

  • Ethics approval This study was approved by NHS Research Ethics Committee (NRES Committee East Midlands - Derby, REC number 14/EM/1280) and was prospectively registered (ISRCTN45041624).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All available study data can be obtained from the corresponding author.

  • Patient consent for publication Not required.

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