Postoperative pain
Conditions
Interventions
Tegileridine Group:Tegileridine 0.1 mg/kg diluted to 100 ml with normal saline for postoperative analgesia.
Sufentanil Group:Postoperative analgesia using Sufentanil 1 µg/kg diluted to 100 ml with normal saline.
Sponsors
The 97th Hospital of the Chinese People's Liberation Army Joint Logistics Support Force
Eligibility
Sex/Gender
All
Age
36 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1) No restrictions on gender; 2) No restrictions on age; 3) Hospitalized patients scheduled for elective total hip arthroplasty; 4) American Society of Anesthesiologists (ASA) Physical Status Classification I–III; 5) No severe cardiovascular or cerebrovascular diseases, normal hepatic and renal function, and no history of anesthesia drug allergy or other special medical conditions; 6) The patient or their legally authorized representative fully understands the purpose and significance of this trial, voluntarily agrees to participate, and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1) Presence of organic diseases in major organs (heart, liver, or kidneys); 2) Use of opioid analgesics or non-steroidal anti-inflammatory drugs within 48 hours prior to surgery; 3) History of chronic pain requiring long-term pharmacological intervention; 4) Contraindications to neuraxial anesthesia; 5) Systolic blood pressure = 90 mmHg within 6 weeks before screening; 6) History of psychiatric disorders (e.g., schizophrenia, depression, etc.) or cognitive dysfunction; history of epilepsy; history of abuse of psychotropic or anesthetic drugs; 7) Abnormal coagulation function (PT or PT-INR > 1.5 times the upper limit of normal, APTT > 1.5 times the upper limit of normal), bleeding tendency (e.g., active peptic ulcer), or ongoing thrombolytic or anticoagulant therapy; 8) Abnormal liver function, with ALT and/or AST > 1.5 times the upper limit of normal; 9) Abnormal renal function, with serum creatinine (Cr) and/or blood urea nitrogen (BUN) > 1.5 times the upper limit of normal; patients on dialysis; 10) Allergy to the ingredients or components of the investigational drug; 11) Participation in other drug clinical trials within the past 3 months; 12) Patients with myasthenia gravis, schizophrenia, or severe depressive state; 13) History of opioid or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale;Ramsay Sedation Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Recovery-15;Rate of rescue analgesia within 24 hours post-surgery;Number of PCIA compressions within 24 hours post-surgery;Pain satisfaction score at 24 hours post-surgery ;Time of first ambulation;time to first flatus; | — |
Countries
China
Contacts
Public ContactLiu Zhiwu; Lu Junjun
The 97th Hospital of the Chinese People's Liberation Army Joint Logistics Support Force
Outcome results
None listed