A randomized, double-blind, positive-controlled clinical study of tegilidine fumarate for postoperative analgesia after shoulder arthroscopy

INTERVENTION: Experimental group:PCIA formula is tagilidine (specific concentration is set according to the preliminary pre‐test results and drug package insert recommendations, currently 0.5 mg/mL is tentatively proposed), background infusion is 2mL/h, self‐controlled addition is 1mL/time, and locking time is 15 minutes.;Control group:The PCIA formulation was HYDROmorphone hydrochloride (40µg/mL), and the background infusion, booster dose and lockout time were consistent with those of the test group.; CONDITION: Postoperative analgesia in patients undergoing shoulder arthroscopy PRIMARY OUTCOME: Area under the time‐weighted curve of resting NRS score within 48 hours after surgery;Incidence of moderate to severe nausea and vomiting and respiratory depression within 48 hours after operation; SECONDARY OUTCOME: Rest and passive activity NRS scores at various time points after surgery;Interleukin‐6 (IL‐6) and C‐reactive protein (CRP) levels; INCLUSION CRITERIA: 1.Age 18‐65 years, ASA class I‐II; 2.Elective unilateral shoulder arthroscopic rotator cuff repair or Bankart repair; 3.PCIA analgesia required after surgery; 4.Informed consent signed