The Library
Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy Pain: 2 (TOPIC 2)
Tools
Shelley, B., Goebel, A., Grant, S., Jackson, L., Jarrett, H., Jepson, M., Kerr, A., Marczin, N., Mehta, R., Melody, T., Middleton, L., Naidu, B., Szentgyorgyi, L., Tearne, S., Watkins, B., Wilson, M., Worrall, A., Yeung, Joyce and Smith, F. (2023) Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy Pain: 2 (TOPIC 2). Trials, 24 . 748. doi:10.1186/s13063-023-07463-1 ISSN 1745-6215.
|
PDF
s13063-023-07463-1.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1009Kb) | Preview |
|
PDF
WRAP-study-protocol-randomised-controlled-trial-investigate-effectiveness-thoracic-epidural-paravertebral-blockade-reducing-chronic-post-thoracotomy-Pain-2-TOPIC-2-Yeung-2023.pdf - Accepted Version Embargoed item. Restricted access to Repository staff only - Requires a PDF viewer. Download (601Kb) |
Official URL: https://doi.org/10.1186/s13063-023-07463-1
Abstract
Background: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost effectiveness in preventing chronic post-thoracotomy pain.
Methods: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomized controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N=1026) will be randomized in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimizing recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at six months post-randomisation defined as ‘worst chest pain over the last week’ equating to a visual analogue score greater than, or equal to 40mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health related quality of life, mortality and a health economic analysis.
Discussion: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS.
Trial registration: NCT03677856 [ClinicalTrials.gov] registered September 19th 2018. https://clinicaltrials.gov/ct2/show/NCT03677856. First patient recruited 8th January 2019.
Item Type: | Journal Article | ||||||
---|---|---|---|---|---|---|---|
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||||
Journal or Publication Title: | Trials | ||||||
Publisher: | Biomed Central | ||||||
ISSN: | 1745-6215 | ||||||
Official Date: | 23 November 2023 | ||||||
Dates: |
|
||||||
Volume: | 24 | ||||||
Article Number: | 748 | ||||||
DOI: | 10.1186/s13063-023-07463-1 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 14 July 2023 | ||||||
Date of first compliant Open Access: | 10 April 2024 | ||||||
Related URLs: | |||||||
Contributors: |
|
Request changes or add full text files to a record
Repository staff actions (login required)
View Item |
Downloads
Downloads per month over past year