SPIRIT flow diagram: schedule of enrolment, interventions and assessments
Timepoint | Enrolment allocation | During the operation | Postoperative follow-up− | |||||||
−D1 | D1 | D01 | D02 | PACU | 2 hours | 4 hours | 12 hours | 24 hours | 48 hours | |
Enrolment | ||||||||||
Patient screening | √ | |||||||||
Informed consent | √ | |||||||||
Allocation | √ | |||||||||
Random assignment | √ | |||||||||
Intervention: | ||||||||||
SF group | √ | |||||||||
OCA group | √ | |||||||||
OCB group | √ | |||||||||
OCC group | √ | |||||||||
Assessments: | ||||||||||
Eligibility criteria | √ | |||||||||
Baseline data | √ | |||||||||
Vital signs | √ | |||||||||
TPVB and assessment | √ | |||||||||
NRS score | √ | √ | √ | √ | √ | √ | ||||
Ramsay score | √ | √ | √ | √ | √ | √ | ||||
Additional analgesic medication | √ | √ | √ | √ | √ | √ | ||||
Consumption of sufentanil or oxycodone | √ | √ | √ | √ | √ | √ | ||||
Number of manual compressions | √ | √ | √ | √ | √ | √ | ||||
Occurrence of adverse reactions: | √ | √ | √ | √ | √ | |||||
PONV | √ | √ | √ | √ | √ | |||||
Respiratory depression | √ | √ | √ | √ | √ | |||||
Pruritus | √ | √ | √ | √ | √ |
−D1, the day before surgery; D01, day of surgery, before the start of the operation; D02, 20 min before the end of the surgery.
NRS, Numerical Rating Scale; PACU, postanaesthesia care unit; PONV, postoperative nausea and vomiting; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; TPVB, thoracic paravertebral nerve block.