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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ISRCTN45041624; Pre-results.
authors.affiliation: Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.|Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Joyce
authors.identifier: 0000-0003-2950-4758
authors.initials: J
authors.lastname: Yeung
authors.affiliation: Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Teresa
authors.initials: T
authors.lastname: Melody
authors.affiliation: Department of Thoracic Surgery, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Amy
authors.initials: A
authors.lastname: Kerr
authors.affiliation: Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.|Department of Thoracic Surgery, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Babu
authors.initials: B
authors.lastname: Naidu
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Lee
authors.initials: L
authors.lastname: Middleton
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Kostas
authors.initials: K
authors.lastname: Tryposkiadis
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.affiliation: Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.|Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Fang
authors.initials: F
authors.lastname: Gao
mesh_terms: D015360:Analgesia, Epidural; D059350:Chronic Pain / Q000188:drug therapy*; D005240:Feasibility Studies; D006801:Humans; D009407:Nerve Block; D010149:Postoperative Pain / Q000188:drug therapy*; D010865:Pilot Projects; D012107:Research Design; D016037:Single-Blind Method; D013904:Thoracic Vertebrae; D013908:Thoracotomy / Q000009:adverse effects*
keywords: Perioperative Medicine