TOPIC Trial

TOPIC logoA Randomised Controlled Trial to investigate the effectiveness of Thoracic Epidural and Paravertebral Blockade in reducing Chronic Post-Thoracotomy Pain.

Design

TOPIC is a randomised controlled trial comparing the effectiveness of thoracic epidural blockade (TEB) and paravertebral blockade (PVB) in reducing chronic post-thoracotomy pain. This is a pilot study to evaluate feasibility of a substantive trial and study processes.

Objectives of Study

The primary objective is to establish the number of patients randomised as a proportion of those eligible to enter the study. Secondary objectives include evaluation of study processes (patient identification and screening processes, failure to recruit, willingness of clinicians to recruit, randomisation process, blinding, data collection and patient follow-up). The size of this study will not allow reliable assessment of the effect of the TEB and PVB on outcomes.

Setting

Two adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM), with a patient case mix and size typical of UK thoracic anaesthetic practice, will take part in this feasibility study.

Target population

  • Aged ≥18 years
  • Elective open thoracotomy
  • American Society of Anaesthesiologists physical status I, II or III

Intervention

Patients will be randomised, on the day of surgery, to either thoracic epidural blockade (TEB) or paravertebral blockade (PVB). Participants will be individually randomised into the study in an equal 1:1 ratio.

Outcomes

Analyses of feasibility and patient reported outcomes will primarily take the form of simple descriptive statistics (e.g. proportions & interquartile ranges, means and standard deviations) and where appropriate, point estimates of effects sizes (e.g. mean differences and relative risks) and associated 95% confidence intervals.

Registration details

ISRCTN 45041624