[Translation] A multicenter, randomized, double-blind, positive and placebo-controlled, dose-escalation and dose-finding phase II clinical trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of local infiltration of ropivacaine sustained-release microspheres for injection (RF16001) for postoperative analgesia after hemorrhoidectomy
主要目的:
1)评估罗哌卡因缓释微球用于痔切除术后镇痛的有效性;
次要目的:
1)评估罗哌卡因缓释微球用于痔切除术后镇痛的安全耐受性;
2)评估罗哌卡因缓释微球在痔切除术患者中的药代动力学特征;
3)探索罗哌卡因缓释微球药用于痔切除术后镇痛的合适剂量。
[Translation] Main purpose:
1) To evaluate the effectiveness of ropivacaine sustained-release microspheres for postoperative analgesia after hemorrhoidectomy;
Secondary purpose:
1) To evaluate the safety and tolerability of ropivacaine sustained-release microspheres for postoperative analgesia after hemorrhoidectomy;
2) To evaluate the pharmacokinetic characteristics of ropivacaine sustained-release microspheres in patients undergoing hemorrhoidectomy;
3) To explore the appropriate dose of ropivacaine sustained-release microspheres for postoperative analgesia after hemorrhoidectomy.