{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T14:03:22Z","timestamp":1765807402303,"version":"3.48.0"},"reference-count":35,"publisher":"BMJ","issue":"12","funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["Research for Patient Benefit Programme grant numbe"],"award-info":[{"award-number":["Research for Patient Benefit Programme grant numbe"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,11,10]]},"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during respiration combine to produce an acute, severe postoperative pain insult and persistent chronic pain many months after surgery is common. Three recent systematic reviews conclude that unilateral continuous paravertebral blockade (PVB) provides analgesia at least equivalent to thoracic epidural blockade (TEB) in the postoperative period, has a lower failure rate, and symptom relief that lasted months. Crucially, PVB may reduce the development of subsequent chronic pain by intercostal nerve protection or decreased nociceptive input. The overall aim is to determine in patients who undergo thoracotomy whether perioperative PVB results in reducing chronic post-thoracotomy pain (CPTP) compared with TEB. This pilot study will evaluate feasibility of a substantive trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>TOPIC is a randomised controlled trial comparing the effectiveness of TEB and PVB in reducing CPTP. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 2 adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM). The primary objective is to establish the number of patients randomised as a proportion of those eligible. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will primarily take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has obtained ethical approval from NHS Research Ethics Committee (REC number 14\/EM\/1280). Dissemination plan includes: informing patients and health professionals; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full HTA application dependent on the success of the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ISRCTN45041624; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-012735","type":"journal-article","created":{"date-parts":[[2016,12,1]],"date-time":"2016-12-01T22:00:26Z","timestamp":1480629626000},"page":"e012735","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol"],"prefix":"10.1136","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2950-4758","authenticated-orcid":false,"given":"Joyce","family":"Yeung","sequence":"first","affiliation":[{"name":"Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK"},{"name":"Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Melody","sequence":"additional","affiliation":[{"name":"Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Kerr","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Heart of England NHS Foundation Trust, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Babu","family":"Naidu","sequence":"additional","affiliation":[{"name":"Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK"},{"name":"Department of Thoracic Surgery, Heart of England NHS Foundation Trust, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lee","family":"Middleton","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kostas","family":"Tryposkiadis","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Daniels","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fang","family":"Gao","sequence":"additional","affiliation":[{"name":"Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK"},{"name":"Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2016,12,1]]},"reference":[{"key":"2025121221110461000_6.12.e012735.1","doi-asserted-by":"publisher","DOI":"10.1097\/00002508-199603000-00009"},{"key":"2025121221110461000_6.12.e012735.2","first-page":"393","article-title":"Analgesia in thoracic surgery: review","volume":"75","author":"De Cosmo","year":"2009","journal-title":"Minerva Anestesiol"},{"key":"2025121221110461000_6.12.e012735.3","first-page":"114","article-title":"Management of pain in thoracic surgery","volume":"50","author":"Sabanathan","year":"1993","journal-title":"Br J Hosp Med"},{"key":"2025121221110461000_6.12.e012735.4","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-200211000-00029"},{"key":"2025121221110461000_6.12.e012735.5","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/ael360"},{"key":"2025121221110461000_6.12.e012735.6","unstructured":"Macrae WA , Davies HTO . 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