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Table 2 Participant timeline

From: 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)

   

Acute phase

Chronic phase

Visit

Screening

Baseline

Day0A

Day 1B

Day 2B

Day 3B

Hospital discharge

Month 3

Month 6

Month 12

Enrolment

 Eligibility check

x

         

 Valid informed consent

 

x

        

 RandomisationC

  

x

       

Baseline medical and demographic data

 Medical history

 

x

        

 Baseline clinical assessmentsD

 

x

        

 Lung function tests (FEV1, FVC, DLCO)E

 

x

        

Clinical data

 Trial intervention

  

x

       

 Complications of regional anaesthesiaF

  

x

x

x

x

x

   

 Resource use (analgesics use etc.)

  

x

x

x

x

x

x

x

x

 Mortality check

  

x

x

x

x

x

x

x

x

 Post-operative surgical complications

  

x

x

x

x

x

   

 Post-operative pulmonary complications

  

x

x

x

x

x

   

 SAE check

  

x

x

x

x

x

x

x

x

Patient reported data

 Pain questionnaires (VAS, BPI)

 

x

 

x

x

x

x

x

xG

x

 Pain questionnaire (SF-MPQ-2)

 

x

    

x

x

x

x

 Quality of life questionnaires (EQ-5D-5L and HADS)

 

x

    

x

x

x

x

 Patient Satisfaction (patient questionnaire)

      

x

x

x

x

 Out of pocket costs incurred by participants

       

x

x

x

 Societal cost (productivity loss etc.)

       

x

x

x

  1. FEV1 Forced expiratory volume in 1 s, FVC Forced vital capacity, DLCO Diffusing capacity for carbon monoxide, SAE Serious adverse event, VAS Visual analogue score, BPI Brief pain inventory, SF-MPQ-2 Short form McGill pain questionnaire
  2. ADay 0 is defined as the day of the intervention (and surgery)
  3. BDay 1 is first full calendar day (from 12 midnight) post-surgery, day 2 is second full calendar day, day 3 is third full calendar day
  4. CRandomisation performed on day of surgery or working day prior to surgery
  5. DTo include: ASA grade, height and weight, ECOG, shortness of breath category, smoking status, alcohol consumption. These should be assessed within 28 days of the intervention
  6. ELung function data can be taken from assessment within past 6 months prior to the intervention
  7. FTo include the following: failure of blockade, hypotension (systolic blood pressure (< 90 mmHg)), inadequate pain relief, low respiratory rate (< 10/min), drowsiness, nausea and vomiting, urinary retention, itching, high block, post-dural puncture headache, vascular puncture, pleural puncture
  8. GIncludes primary outcome—‘worst chest pain over the last week’ on a 100-mm visual analogue scale