{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T06:22:36Z","timestamp":1770790956087,"version":"3.50.0"},"reference-count":46,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["16\/111\/111"],"award-info":[{"award-number":["16\/111\/111"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>More than a third of patients undergoing thoracotomy suffer from debilitating chronic post-thoracotomy pain lasting months or years postoperatively. Aggressive management of acute pain during the perioperative period may mitigate this risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-2\">\n                    <jats:title>Objective(s)<\/jats:title>\n                    <jats:p>To determine the clinical and cost-effectiveness of paravertebral blockade compared to thoracic epidural blockade, by testing the hypothesis that paravertebral blockade reduces the incidence of chronic post-thoracotomy pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-3\">\n                    <jats:title>Design and methods<\/jats:title>\n                    <jats:p>A parallel, open, multicentre, randomised controlled with integrated health-economic evaluation and an internal pilot that incorporated a qualitative recruitment intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-4\">\n                    <jats:title>Setting and participants<\/jats:title>\n                    <jats:p>Adult patients undergoing thoracotomy in 15 United Kingdom centres.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-5\">\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Paravertebral blockade compared to thoracic epidural blockade.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-6\">\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary outcome was the presence of chronic post-thoracotomy pain at 6 months post randomisation defined as \u2018worst chest pain over the last week\u2019 of at least moderate intensity, with a visual analogue scale score \u2265\u200540\u2005mm. Secondary outcomes included visual analogue scale pain scores in the acute (days 1, 2, 3 and discharge) and chronic (3, 6 and 12 months) phases postoperatively; Brief Pain Inventory; Short Form McGill Pain Questionnaire 2; Hospital Anxiety and Depression Scale; patient satisfaction; analgesia use in the acute and chronic phases; complications (analgesic, surgical and pulmonary) and mortality. For the economic evaluation, the EuroQol-5 Dimensions, five-level version questionnaire was utilised.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-7\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 8 January 2019 and 29 September 2023, 770 patients underwent randomisation; 33 did not proceed to thoracotomy. At 6 months, 59 (22%) of 272 participants in the paravertebral blockade group and 47 (16%) of 292 in the thoracic epidural blockade group developed chronic pain [adjusted risk ratio\u2005=\u20051.32 (95% confidence interval 0.93 to 1.86); adjusted risk difference\u2005=\u20050.05 (95% confidence interval \u22120.01 to 0.11);\n                      <jats:italic>p<\/jats:italic>\n                      \u2005=\u20050.12]. During the acute phase, both worst and average pain was higher on day 1 with paravertebral blockade [adjusted mean difference 7.7\u2005mm (95% confidence interval 2.8 to 12.5) and 7.0\u2005mm (95% confidence interval 2.7 to 11.2), respectively] but not different on days 2 and 3. Hypotension was less common in the paravertebral blockade group [adjusted risk ratio\u2005=\u20050.66 (95% confidence interval 0.46 to 0.94)], and overall complications were comparable between groups. The health-economic analysis demonstrated that thoracic epidural blockade produced an additional 0.04 quality-adjusted life-years when compared to paravertebral blockade, and was associated with slightly lower costs, but these differences were not statistically significant.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-8\">\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>The main limitation is the reduced sample size from 1026 to 770, which reduced the associated power from 90% to 80%. The key reasons are related to practice change over time resulting in a downgrade in equipoise and the COVID pandemic. Also, we cannot rule out that lack of blinding may have had some impact on the acute phase outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-9\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In our study, paravertebral blockade and thoracic epidural blockade appear to be equivalent in clinical and cost-effectiveness in preventing chronic post-thoracotomy at 6 months; this may be paving the way for both techniques likely to continue in National Health Service thoracic settings, based on clinician and patient\u2019s choices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-10\">\n                    <jats:title>Future work<\/jats:title>\n                    <jats:p>Using full TOPIC-2 data sets, defined according to the European Society of Thoracic Surgeons data set, to explore the trajectory of the development from acute to chronic post-surgery pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-11\">\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16\/111\/111.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3310\/gjfg1715","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T07:46:57Z","timestamp":1752565617000},"page":"1-21","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["The clinical and cost-effectiveness of paravertebral blockade versus thoracic epidural blockade in reducing chronic post-thoracotomy pain: TOPIC2 RCT 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