Clinical Research Directory

Participants receive a preoperative regional nerve block as soon as possible after randomization. Ultrasound guidance is recommended, and fascia iliaca block is the recommended block technique.

Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.

For participants randomized to the nerve block group, 1.33% bupivacaine liposome is recommended as a long-acting local anesthetic, with a maximum dose not exceeding 133 mg, to maintain the continuity of the nerve block effect.

For participants randomized to the nerve block group, regular local anesthetic, such as bupivacaine or ropivacaine, may be used with continuous electronic analgesic pump infusion or multiple single injections to maintain the continuity of the nerve block effect.

Participants randomized to the lidocaine group receive ECG monitoring, oxygen saturation monitoring, blood pressure monitoring, and an open intravenous route on the morning of surgery. It is recommended to start the infusion of lidocaine as soon as possible in the ward. A portable electronic infusion pump is recommended for drug delivery. The loading dose is 1 mg/kg, and the maintenance dose range is 1 to 2 mg/kg/h. The specific dose is determined by the anesthesiologist according to the patient's condition. The infusion ends when the patient leaves the post-anesthesia care unit after surgery, and the infusion time and total amount are recorded. Intravenous infusion of lidocaine should be administered under ECG monitoring.

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.