Evaluation of Safety and Efficacy of Nalbuphine Versus Mo... | NCT06949852

Status Module

Label	Type	Description	Intervention Names
Nalbuphine group	Experimental		Drug: Nalbuphine Hydrochloride Injection
Morphine group	Active Comparator		Drug: Morphine Hydrochloride Injection

Name	Type	Description	Arm Group Labels	Other Names
Nalbuphine Hydrochloride Injection	Drug	PCIA，The lockout interval is set at 10 minutes, with no background infusion.	Nalbuphine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sum of Pain Intensity Difference over 0-48 hours(SPID48)	SPID48=∑PID48×[time in hours slapsed since the previous observation], PID48 denotes the pain intensity difference at time 48 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."	0-48 hours

Secondary Outcomes

Measure	Description	Time Frame
Sum of Pain Intensity Difference over 0-12 hours(SPID12)	SPID12=∑PID12×[time in hours slapsed since the previous observation], PID12 denotes the pain intensity difference at time 12 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 years (inclusive), regardless of gender.
Weight 45-100 kg (inclusive) and BMI 18.0-30.0 kg/m² (inclusive).
Preoperative ASA Physical Status Class I-III.
Scheduled for elective general anesthesia in abdominal surgery (single incision ≥5 cm) or orthopedic surgery (limb/joint procedures); completed anesthesia recovery within 4 hours postoperatively, with NRS score ≥4, and willingness to accept protocol-defined analgesia.
Ability to comprehend study objectives, operate PCIA devices, and communicate effectively with investigators.
Female subjects must be non-pregnant, non-lactating, and agree to use contraception (including partners) for 3 months post-study.
Voluntary participation with signed informed consent.

Exclusion Criteria:

Known or suspected allergy/hypersensitivity to any component of the investigational product, other opioids, or contraindicated drugs specified in the protocol .
Neurological/psychiatric disorders including:
1. Clinically significant neurological diseases (e.g., epilepsy, cognitive impairment) .
2. History of brain injury, increased intracranial pressure, or psychiatric disorders (e.g., schizophrenia, bipolar disorder, depression, anxiety) that may interfere with safety or study assessments as judged by the investigator .
Cardiovascular diseases/history:
1. Severe cardiovascular conditions (NYHA Class II or higher), myocardial infarction, angina, or severe arrhythmia within the past year .
2. Abnormal 12-lead ECG findings during screening (e.g., sinus bradycardia ≤55 bpm, ≥Grade II AV block) deemed unsuitable by the investigator .
3. Resting systolic blood pressure ≥160 mmHg or <90 mmHg, diastolic ≥100 mmHg pre-surgery .
4. Intraoperative circulatory instability (e.g., hypotension, bradycardia) assessed as high-risk for trial continuation .
Respiratory disorders/history:
1. Bronchial asthma, high-risk respiratory depression conditions (e.g., severe COPD ≥GOLD 3, sleep apnea syndrome) .
2. Preoperative SpO2 <93% (room air) or intraoperative respiratory depression/ventilatory dysfunction deemed unsafe .
Paralytic ileus, biliary/pancreatic diseases within 12 months before screening .
Major surgery within 3 months prior to screening.
Acute/chronic non-surgical pain interfering with postoperative pain assessment .
Preoperative anemia: Hemoglobin <70 g/L or hematocrit <25% .
High bleeding risk:
1. Congenital bleeding disorders (e.g., hemophilia) .
2. Platelet count <0.75×LLN, PT >ULN+3s, or APTT >ULN+10s .
Organ dysfunction:
1. Albumin <35 g/L (untreated) .
2. Liver/kidney function abnormalities: TBIL/ALT/AST/ALP ≥1.5×ULN ; Creatinine ≥1.5×ULN or clinically significant renal impairment; Recent dialysis (within 28 days) .
Random blood glucose ≥11.1 mmol/L during screening (preoperative) .
Participation in other clinical trials with active treatment within 3 months before surgery .
Other conditions deemed unsuitable by the investigator for safety or protocol compliance.

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing			China
Cangzhou People's Hospital

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds