Schedule of data collection
Data item | Prerandomisation | Presurgery | Intra operative | Postsurgery (until discharge) | Discharge | 4 weeks post surgery | 4 months post surgery |
Sociodemographic details | ✓ | ||||||
Comorbidities | ✓ | ||||||
Routine clinical measures | ✓ | ✓ | |||||
Resource use schedule | ✓ | ✓ | ✓ | ||||
SF-12 | ✓ | ✓ | ✓ | ||||
EQ-5D 5L | ✓ | ✓ | ✓ | ||||
BPI | ✓ | ✓ | ✓ | ||||
NRS pain score | ✓* | ✓* | ✓ | ||||
Study medication | ✓ | ✓† | |||||
Opioid use | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Adverse events | ✓ | ✓ | |||||
Serious adverse events | ✓ | ✓ | ✓ | ✓ |
*Routinely collected NRS pain scores as close as possible to the following time points may be used: prerandomisation, 1 hour, 4 hours, 12 hours postsurgery and two times per day postsurgery until discharge. NRS pain assessments will not be possible in intubated patients.
†Study medication given morning and evening for 2 days following extubation (where applicable).
BPI, brief pain inventory; NRS, numerical rating scale.