This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy(TLH). Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary objective is to determine if a single application of an equivalent dose of Tegileridine or Oxycodone can keep VAS scores at or below 3 during the anesthesia recovery phase. The secondary objectives are to compare cumulative opioid consumption within 48 hours postoperatively, time to first rescue analgesia, and the incidence rate of adverse events, such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Tegileridine (tegileridine fumarate injection, IV) is a small-molecule μ-opioid receptor agonist with G-protein-biased signaling (relative to β-arrestin-2 recruitment), developed by Jiangsu Hengrui for postoperative analgesia. It is administered intravenously and was first approved in China in January 2024 for the treatment of moderate-to-severe pain after abdominal surgery; in this study, tegileridine is used as part of standardized multimodal analgesia according to protocol. In China it is regulated as a narcotic drug.
Oxycodone bitartrate is a dual opioid receptor agonist that is used in clinical settings. Oxycodone bitartrate injection is indicated for the relief of moderate to severe cancer pain. It can be administered alone or in combination with non-steroidal anti-inflammatory drugs to provide acute combined analgesia. In January 2021, Jiangsu Enhua Pharmaceutical submitted a marketing authorisation application for Oxycodone bitartrate injection to the National Medical Products Administration.The application has been accepted and approved.
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
Haikou, China
RECRUITINGSuccess rate of postoperative pain management
Following extubation during anaesthesia recovery after surgery, pain intensity was assessed at rest using a 10-cm visual analogue scale (VAS) by a blinded evaluator (with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the most severe pain imaginable). Analgesia was recorded as successful when the VAS score was ≤3; otherwise, it was considered unsuccessful.
Time frame: After the surgery, before leaving the recovery room(Day 0)
Time of First Pressing of the PCIA
Time of First Postoperative Pressing of the Patient-Controlled Intravenous Analgesia(PCIA) pump
Time frame: Within 48 hours after surgery
Overall incidence of adverse reactions
Incidence of Postoperative nausea and vomiting, hypotension, nasal congestion, dizziness, respiratory depression, delayed emergence from anesthesia, pruritus, muscle rigidity, convulsions, constipation, urinary retention, agitation during emergence, and convulsions.
Time frame: Within 48 hours after surgery
Richmond Agitation and Sedation Scale(RASS)
The research team assigns a RASS score (minimum -5 = unarousable, maximum +4 = combative; scores closer to 0 indicate an alert and calm state) by observing the patient immediately before tracheal extubation.
Time frame: Immediately before removal of the endotracheal tube (Postoperative Day 0).
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