Trial visits
SAEs, CRF, pain
ADVERSE EVENTS, SECONDARY, CRF
The trial includes a total of nine study visits during the operation and the postoperative period. The inclusion and exclusion criteria will be evaluated during the screening visit (the day before the operation). After the patient has given his or her informed consent, the demographic and baseline data, medical history, current medication, comorbidities, American Society of Anaesthesiologists (ASA) classification, and ECOG status will be evaluated and documented. Randomization will be performed intraoperatively by authorized study personnel, and intraoperative parameters will be collected.Patients are followed up until discharge. Study visits will be scheduled on postoperative days 1 to 7 and on the day of discharge from the hospital. There will also be a daily visit by the pain service until the epidural catheter is removed. Primary and secondary endpoints and (serious) adverse events (SAEs and AEs) will be evaluated and documented during each visit and documented on the case report form (CRF). All planned study visits are summarized in Table Study visits