Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia

NCT06949852 | Recruiting Phase 3

• 1 other identifier: YZJ-NBF-YZ-2303
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 24

Brief Summary

Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• Sum of Pain Intensity Difference over 0-12 hours(SPID12)

  0-12 hours

• Sum of Pain Intensity Difference over 0-24 hours(SPID24)

  0-24 hours

• Sum of Pain Intensity Difference over 0-32 hours(SPID32)

  0-32 hours

• Total Number of PCIA Pump attempts during 0~48h

  0-48 hours

• Number of Effective Deliveries during 0~48h

  0-48 hours

Study Arms (2)

Nalbuphine group

EXPERIMENTAL

Drug: Nalbuphine Hydrochloride Injection

Morphine group

ACTIVE COMPARATOR

Drug: Morphine Hydrochloride Injection

Interventions

Nalbuphine Hydrochloride Injection DRUG

PCIA，The lockout interval is set at 10 minutes, with no background infusion.

Nalbuphine group

Morphine Hydrochloride Injection DRUG

PCIA，The lockout interval is set at 10 minutes, with no background infusion.

Morphine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Clinically significant neurological diseases (e.g., epilepsy, cognitive impairment) .
• 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:
• Severe cardiovascular conditions (NYHA Class II or higher), myocardial infarction, angina, or severe arrhythmia within the past year .
• Abnormal 12-lead ECG findings during screening (e.g., sinus bradycardia ≤55 bpm, ≥Grade II AV block) deemed unsuitable by the investigator .
• Resting systolic blood pressure ≥160 mmHg or \<90 mmHg, diastolic ≥100 mmHg pre-surgery .
• Intraoperative circulatory instability (e.g., hypotension, bradycardia) assessed as high-risk for trial continuation .
• Respiratory disorders/history:
• Bronchial asthma, high-risk respiratory depression conditions (e.g., severe COPD ≥GOLD 3, sleep apnea syndrome) .
• 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 .

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd: lead

Study Sites (24)

Peking University First Hospital

Beijing, China

RECRUITING

Cangzhou People's Hospital

Cangzhou, China

RECRUITING

The First People's Hospital of Changde City

Changde, China

RECRUITING

The Third Xiangya Hospital of Central South Univerdity

Changsha, China

RECRUITING

Heping Hospital affiliated to Changzhi Medical College

Changzhi, China

RECRUITING

Chengdu Fifth People's Hospital

Chengdu, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, China

RECRUITING

Chongqing University Affiliated Fuling Central Hospital

Chongqing, China

RECRUITING

Deyang People's Hospital

Deyang, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, China

RECRUITING

The First Affiliated Hospital Of University Of South China

Hengyang, China

RECRUITING

The Second Affiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

The First People's Hospital of Lianyungang

Lianyungang, China

RECRUITING

Liuzhou Worker's Hospital

Liuchow, China

RECRUITING

Mianyang Central Hospital

Mianyang, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, China

RECRUITING

The Second Nanning People's Hospital

Nanning, China

RECRUITING

Ningbo Medical Center LIHUILI Hospital

Ningbo, China

RECRUITING

Ningbo NO.2 Hospital

Ningbo, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, China

RECRUITING

The First Affiliated Hospital of Wannan Medical College

Wuhu, China

RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, China

RECRUITING

Xi'an Honghui Hospital

Xi'an, China

RECRUITING

MeSH Terms

Interventions

Nalbuphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 29, 2025
• Study Start: August 7, 2024
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CN (24)