[Translation] A randomized, double-blind, active drug parallel-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of HYR-PB21 for injection via the popliteal approach under ultrasound guidance for postoperative analgesia in patients undergoing open reduction and internal fixation of unilateral ankle fractures
主要目的:以盐酸布比卡因注射液为对照,评价HYR-PB21用于单侧足踝部骨折切开复位内固定手术患者术后镇痛治疗的有效性。
次要目的:(1)观察试验药物和阳性对照药AE发生情况,评价HYR-PB21用于单侧足踝部骨折切开复位内固定手术患者术后镇痛治疗的安全性。(2)考察腘窝入路坐骨神经阻滞给药途径下,HYR-PB21的血浆布比卡因药代动力学特征。
[Translation] Primary objective: To evaluate the effectiveness of HYR-PB21 in postoperative analgesia in patients undergoing open reduction and internal fixation of unilateral ankle fractures, using bupivacaine hydrochloride injection as a control.
Secondary objectives: (1) To observe the occurrence of AEs of the test drug and the positive control drug, and to evaluate the safety of HYR-PB21 in postoperative analgesia in patients undergoing open reduction and internal fixation of unilateral ankle fractures. (2) To investigate the pharmacokinetic characteristics of plasma bupivacaine in HYR-PB21 under the administration route of popliteal approach sciatic nerve block.