Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

May 1, 2025

Study Completion Date

May 10, 2025

Conditions
Upper Limb Injury
Interventions
DEVICE

General Anesthesia (GA)

Anesthesia induction will be achieved using propofol (1.5-2 mg/kg i.v.), rocuronium (1-2 mg/kg i.v.), and fentanyl (1-2 μg/kg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg/kg/min) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.

DEVICE

Continuous Brachial Plexus Block

Patients were positioned supine with the head slightly turned to the contralateral side to expose the supraclavicular fossa. The injection site was prepared using standard aseptic techniques. Under ultrasound guidance, a needle was advanced to the vicinity of the brachial plexus. Aspiration was performed to confirm the absence of blood return before the slow, incremental injection of either liposomal bupivacaine \[adult dose: 133 mg (10 mL) to 266 mg (20 mL)\] or ropivacaine \[adult dose: 20 mL of 0.5% ropivacaine, administered via continuous infusion at a rate of 5-10 mL/h; pediatric dose: 0.1% ropivacaine at 0.1-0.2 mL/kg, administered via continuous infusion at 0.05-0.15 mL/kg/h\]. Patient responses were closely monitored throughout the procedure.

Trial Locations (1)

014010

Inner Mongolia Baogang Hospital, Baotou

All Listed Sponsors
lead

Xiaguang Duan

OTHER

NCT06779643 - Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery | Biotech Hunter | Biotech Hunter