This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of tegileridine fumarate injection for postoperative analgesia in adults experiencing moderate-to-severe pain after abdominal surgery. Participants will be randomized to receive intravenous tegileridine or matching placebo as part of a standardized multimodal analgesia protocol; all patients will have access to rescue opioid analgesia per institutional practice. The primary objective is to determine whether tegileridine improves postoperative pain control during the first 24-48 hours after surgery. Secondary objectives include comparing cumulative opioid consumption, time to first rescue analgesia, patient-reported satisfaction with pain control, recovery milestones (e.g., time to ambulation), and the incidence of adverse events such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study with predefined stopping and reporting procedures. The results aim to inform whether tegileridine can provide effective and well-tolerated analgesia for patients with moderate-to-severe postoperative pain following abdominal procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
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.
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
Haikou, China
Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points
Pain intensity is assessed with the 10-cm Visual Analog Scale (minimum 0 = no pain, maximum 10 = worst imaginable pain) at rest by blinded assessors at 2 h, 6 h, 12 h, 24 h, 36 h and 48 h after surgery; lower scores indicate less pain. When rescue analgesia is required, VAS is recorded immediately before rescue dosing.
Time frame: 2 hours ( h), 6 h, 12 h, 24 h, 36 h and 48 h after surgery
Intraoperative opioid consumption
Total intraoperative opioid use, expressed in intravenous morphine milligram equivalents.
Time frame: Perioperative (induction of anesthesia to end of surgery).
Quality of Recovery-15 (QoR-15) Score
Researchers assist patients in completing the QoR-15 questionnaire (minimum 0 = very poor quality of recovery, maximum 150 = excellent quality of recovery); higher scores indicate better quality of recovery.
Time frame: Day 1 and Day 2 postoperatively.
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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