post-operative pain
Conditions
Interventions
Tegileridine Group (Group T):Single intravenous dose of 1 mg administered via slow pump infusion over 10 minutes
30 minutes after the start of the initial dose, a Patient-Controlled Analgesia (PCA) dose of 0.1 mg is available.
Hydromorphone Group (Group M):Single intravenous dose of 0.5 mg
30 minutes after the administration of the initial dose, a PCA dose of 0.2 mg is available.
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Undergoing elective laparoscopic radical resection of colorectal tumors under general anesthesia, with an operation duration >= 1.5 hours; 2. Aged between 18 and 65 years (inclusive); 3. Body mass index (BMI) between 18 kg/m² and 30 kg/m² (inclusive); 4. American Society of Anesthesiologists (ASA) physical status classification ?–?; 5. Voluntarily sign the informed consent form prior to the initiation of trial-related activities, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of bronchial asthma; 2.Patients with a history of severe cardiovascular or cerebrovascular diseases (e.g., myocardial infarction or unstable angina pectoris, history of severe arrhythmias such as atrioventricular block, New York Heart Association [NYHA] functional class ? or above, or ischemic stroke); 3.Patients with known or suspected gastrointestinal obstruction, including paralytic ileus; 4.Patients with a history of allergy to opioids or any component of the investigational drug; 5.Patients with a history of psychiatric disorders (e.g., schizophrenia, depression) or cognitive dysfunction; 6.Patients with advanced malignant tumors or those with extensive metastasis; 7.Patients with other physical pain conditions that may interfere with the postoperative pain assessment; 8.History of drug abuse, substance abuse, and/or alcoholism within one year prior to randomization; 9.Female patients who are pregnant or breastfeeding; 10.Patients with any other condition that, in the investigator's judgment, makes them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve for the Numerical Rating Scale (NRS) pain score at rest within 0–24 hours post-surgery (AUC R-0-24h);Incidence of postoperative respiratory depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain scores at rest and upon movement at 30 min, 1 h, 6 h, 12 h, 24 h, and 48 h after tracheal extubation;Area under the curve for NRS pain scores at rest (AUC R-0-6h, AUC R-0-12h, AUC R-0-48h) and upon movement (AUC A-0-6h , AUC A-0-12h, AUC A-0-24h, AUC A-0-48h) during respective time intervals;Time to first use of rescue analgesia;;Proportion of subjects requiring rescue analgesia, number of rescue doses, and amount of rescue medication used;Total number of PCA pump attempts and number of effective deliveries;Postoperative nausea VAS and VDS scores;Incidence and frequency of postoperative vomiting;Duration of postoperative hospital stay;Subject and investigator satisfaction scores regarding analgesia; | — |
Countries
China
Contacts
Public ContactFang Jieyu
Department of Anesthesiology, The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed