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Table 3 Case report forms and data collection

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)

Form name

Contents

Baseline Medical Data Form

Height, weight, ECOG status, ASA grade, performance status, medical history, smoking status and history, lung function,

Patient Completed Booklet Hospital Baseline

Pain questionnaires: VAS, BPI and SF-MPQ-2. QoL – EQ-5D-5L, HADS,

Intervention Form

Analgesia administered in theatre and recovery, intraoperative monitoring, analgesic intervention performed, difficulties and complications with block, local anaesthetic administered

Operation Details Form

Operation type, operator, side, approach, muscle/nerve sparing, rib resection or fractures, chest drainage, histology

Acute Phase patient completed booklet (Day 1A, Day 2A, Day 3A)

Pain questionnaires: VAS and BPI

Acute Day 0A Post Recovery Form

Management of LA block—top-ups, resiting and discontinuation. Analgesia administered. Return to theatre

Acute Phase Up To Day 3A Form

Ward location. Management of LA block—top-ups, resiting and discontinuation. Analgesia administered. Complications and severity (Table 3), return to theatre

Acute Phase Day 4 to Discharge Form

Postoperative analgesia administered. Complications and severity (Table 3), return to theatre

Patient Completed Booklet Hospital Discharge

Patient satisfaction questionnaire. Pain questionnaires: VAS, BPI and SF-MPQ-2. QoL – EQ-5D-5L. HADS

Chronic Phase patient completed booklet (3, 6 and 12 months)

Patient satisfaction questionnaire. Pain questionnaires: VAS, BPI and SF-MPQ-2. QoL – EQ-5D-5L. HADS

Health Contacts Form (3, 6 and 12 months)

NHS Care visits: A&E visits, hospital admissions and investigations received

Private healthcare costs. Medications and equipment. Occupation and activities

  1. ASA grade American Society of Anaesthetists, BPI Brief pain inventory, ECOG Eastern Cooperative Oncology Group, HADS Hospital Anxiety and Depression Scale, QoL Quality of life, SF-MPQ-2 Short form McGill pain questionnaire, VAS Visual analogue score
  2. ADay 0 is defined as the day of the intervention (and surgery), Day 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