Schedule of enrolment, interventions, data collection and outcome assessments
Time point | Operation | Postoperation follow-up | ||||
Preoperation | During operation | 2 days after surgery | 5 days after surgery | 3 months | 6 months | |
Enrolment | ||||||
Eligibility screen | ✖ | |||||
Recruitment | ✖ | |||||
Consent | ✖ | |||||
Randomisation and allocation | ✖ | |||||
Intervention | ||||||
Opioid-free anaesthesia group or opioid-based control group | ✖ | |||||
Prerandomisation data collection | ||||||
Demographics | ✖ | |||||
Physical examination | ✖ | |||||
Laboratory results | ✖ | |||||
Neurological examination | ✖ | |||||
Daily data collection | ||||||
Intraoperative vital signs | ✖ | |||||
The use of antiemetic drugs | ✖ | |||||
The use of analgesic drugs | ✖ | ✖ | ✖ | ✖ | ||
Laboratory results | ✖ | ✖ | ||||
Primary outcome | ||||||
QoR-15 Score on the second day after surgery | ✖ | |||||
Secondary outcomes | ||||||
QoR-15 Score on the fifth day after surgery | ✖ | |||||
Postoperative nausea and vomiting | ✖ | |||||
NRS Pain Score | ✖ | ✖ | ✖ | ✖ | ||
Postoperative sleep quality | ✖ | ✖ |
NRS, Numerical Rating Scale; QoR, quality of recovery.