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

April 21, 2025 updated by: Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Nalbuphine Versus Morphine for the Treatment of Postoperative Analgesia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Cangzhou, China
        • Recruiting
        • Cangzhou People's Hospital
        • Contact:
      • Changde, China
        • Recruiting
        • The First People's Hospital of Changde City
        • Contact:
      • Changsha, China
        • Recruiting
        • The Third Xiangya Hospital of Central South Univerdity
        • Contact:
      • Changzhi, China
        • Recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Chengdu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, China
        • Recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
      • Chongqing, China
        • Recruiting
        • Chongqing University Affiliated Fuling Central Hospital
        • Contact:
      • Deyang, China
        • Recruiting
        • Deyang People's Hospital
        • Contact:
      • Fuzhou, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:
      • Hengyang, China
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
      • Jiaxing, China
        • Recruiting
        • The Second Affiliated Hospital of Jiaxing University
        • Contact:
      • Lianyungang, China
        • Recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
      • Liuzhou, China
      • Mianyang, China
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
      • Nanjing, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanning, China
        • Recruiting
        • The Second Nanning People's Hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo No.2 Hospital
        • Contact:
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Wuhu, China
        • Recruiting
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
      • Wuxi, China
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:
      • Xi'an, China
        • Recruiting
        • Xi'an Honghui Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-65 years (inclusive), regardless of gender.
  2. Weight 45-100 kg (inclusive) and BMI 18.0-30.0 kg/m² (inclusive).
  3. Preoperative ASA Physical Status Class I-III.
  4. 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.
  5. Ability to comprehend study objectives, operate PCIA devices, and communicate effectively with investigators.
  6. Female subjects must be non-pregnant, non-lactating, and agree to use contraception (including partners) for 3 months post-study.
  7. Voluntary participation with signed informed consent.

Exclusion Criteria:

  1. Known or suspected allergy/hypersensitivity to any component of the investigational product, other opioids, or contraindicated drugs specified in the protocol .

  2. 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 .

  3. 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 .

  4. 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 .
  5. Paralytic ileus, biliary/pancreatic diseases within 12 months before screening .
  6. Major surgery within 3 months prior to screening.
  7. Acute/chronic non-surgical pain interfering with postoperative pain assessment .
  8. Preoperative anemia: Hemoglobin <70 g/L or hematocrit <25% .

  9. High bleeding risk:

    1. Congenital bleeding disorders (e.g., hemophilia) .
    2. Platelet count <0.75×LLN, PT >ULN+3s, or APTT >ULN+10s .

  10. 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) .
  11. Random blood glucose ≥11.1 mmol/L during screening (preoperative) .
  12. Participation in other clinical trials with active treatment within 3 months before surgery .
  13. Other conditions deemed unsuitable by the investigator for safety or protocol compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalbuphine group
Drug: Nalbuphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Active Comparator: Morphine group
Drug: Morphine Hydrochloride Injection
PCIA，The lockout interval is set at 10 minutes, with no background infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of Pain Intensity Difference over 0-48 hours(SPID48)
Time Frame: 0-48 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of Pain Intensity Difference over 0-12 hours(SPID12)
Time Frame: 0-12 hours
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."
0-12 hours
Sum of Pain Intensity Difference over 0-24 hours(SPID24)
Time Frame: 0-24 hours
SPID24=∑PID24×[time in hours slapsed since the previous observation], PID24 denotes the pain intensity difference at time 24 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."
0-24 hours
Sum of Pain Intensity Difference over 0-32 hours(SPID32)
Time Frame: 0-32 hours
SPID32=∑PID32×[time in hours slapsed since the previous observation], PID32 denotes the pain intensity difference at time 32 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."
0-32 hours
Total Number of PCIA Pump attempts during 0~48h
Time Frame: 0-48 hours
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation & Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
0-48 hours
Number of Effective Deliveries during 0~48h
Time Frame: 0-48 hours
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation & Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
0-48 hours
Total Delivered Dose during 0~48h
Time Frame: 0-48 hours
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation & Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
0-48 hours
Time to First Use of Rescue Medication
Time Frame: 0-48 hours
Time to first use of rescue medication during 0~48h.(For subjects with inadequate pain control (NRS score ≥4) who consent to rescue therapy, the following conditions must be met before administering rescue medication: 1) NRS score remains ≥4 within 5 minutes prior to rescue drug administration; 2) At least 5 minutes have elapsed since the last effective PCIA pump press, and the next PCIA bolus is not yet due)
0-48 hours
Proportion of Subjects Requiring Rescue Medication
Time Frame: 0-48 hours
0-48 hours
Number of Rescue Medication Administrations
Time Frame: 0-48 hours
0-48 hours
Proportion of Subjects with Treatment Failure
Time Frame: 0-48 hours
0-48 hours
Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose
Time Frame: 0-48 hours
The PGIC scale (6-point) will be administered at 48h (±30min) post-dose to evaluate patients' perceived change in analgesia, ranging from 'Very much improved' (1) to 'Much worse' (6).
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZJ-NBF-YZ-2303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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