Choose to undergo abdominal surgery under general anesthesia (with an expected maximum incision of = 5cm) or orthopedic surgery (limb and joint surgery), and the expected postoperative pain is moderate to severe
Conditions
Interventions
Control group:Prepare 200mg of nalbuphine hydrochloride into a 200ml solution using 0.9% sodium chloride injection
Use an analgesic pump, no background infusion, PCIA single dose of 2mg (2ml/time), locked in time of 10 minutes, cumulative total dose not exceeding 120mg within 24 hours, administered for a total of
Test group:100mg of morphine hydrochloride was prepared into a 200ml solution using 0.9% sodium chloride injection. The solution was administered using an analgesic pump without background infusion. T
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65 years old (including critical values), regardless of gender; 2. Weight: 50-100kg (including critical value), with a body mass index (BMI) of 18.0-30.0kg/m^2 (including critical value); 3. The preoperative American Society of Anesthesiologists (ASA) grading ranges from grade I to grade III; 4. Choose to undergo general anesthesia for abdominal surgery (with a single maximum incision of = 5cm) or orthopedic surgery (for limb and joint surgery); Subjects who complete anesthesia resuscitation and wakefulness within 4 hours after surgery, are able to accurately complete the NRS scale score, and have an NRS score of >= 4, and are willing to accept the pain relief method set by the research protocol; 5. Can understand the purpose, process, and scale scoring method of this experiment, the subjects can operate PCIA equipment, and can communicate effectively with the researchers; 6. Female subjects who are not pregnant or breastfeeding; The subject voluntarily adopts appropriate contraceptive measures (including partners) within 3 months after signing the informed consent form and has no plans to donate sperm/eggs; 7. The subjects voluntarily participate in this trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected to be allergic or contraindicated to the components of the investigational drug or other opioid drugs or other drugs specified during the trial process; 2. Known neurological and psychiatric disorders, such as clinically significant neurological disorders such as epilepsy and cognitive impairment; And other neurological and psychiatric disorders such as brain injury, increased intracranial pressure, or the presence of schizophrenia, bipolar disorder, depression, anxiety, etc. that may affect the central nervous system function, as assessed by the researchers, may affect the safety of the subjects or interfere with the research evaluators; Have the following cardiovascular diseases or medical history:; 3. Have the following cardiovascular diseases or medical history: a) Severe cardiovascular system disease, with a New York Heart Association (NYHA) heart function classification of level II or above; Have experienced myocardial infarction, angina, and severe arrhythmia within the past year; b) Screening period electrocardiogram abnormalities: sinus bradycardia (heart rate = 160mmHg, or= 100mmHg in a resting state; d) Subjects with circulatory system abnormalities (such as hypotension, bradycardia, etc.) that occur from the start of anesthesia induction to randomization and have been assessed by the researcher as unsuitable for further participation in this study; 4. Having the following respiratory system diseases or medical history: a) having a history or current high risk of bronchial asthma, respiratory depression (such as chronic obstructive pulmonary disease, sleep apnea syndrome, etc.), or other serious respiratory system diseases; b) Subjects with blood oxygen saturation (SpO2) during the screening period (not oxygenated)upper limit of normal value (ULN)+3s, or activated partial thromboplastin time (APTT) >ULN+10s; 10. For individuals with serum albumin (ALB)<35g/L during the screening period and without treatment, serum total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Poor total pain intensity within 0-48 hours (SPID48); | — |
Secondary
| Measure | Time frame |
|---|---|
| SPID12, SPID24, SPID36;Proportion of Subjects with Treatment Failure;Time to First Use of Rescue Medication;Number of Rescue Medication Administrations?;Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose;Proportion of Subjects Requiring Rescue Medication?;Total Number of Pump Presses, Number of; | — |
Countries
China
Contacts
Public ContactWang Dongxin
Peking University First Hospital
Outcome results
None listed