Postoperative AnalgesiaPhase 3NCT06949852
Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia
A Phase 3 study testing Nalbuphine Hydrochloride Injection and Morphine Hydrochloride Injection in people with Postoperative Analgesia, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 24 sites in China.
Trial summary
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Nalbuphine Hydrochloride Injection and Morphine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 24 sitesChina
- Study dates
- 7 Aug 2024to 4 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
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- 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 .
- Preoperative anemia: Hemoglobin <70 g/L or hematocrit <25% .
- High bleeding risk:
- Congenital bleeding disorders (e.g., hemophilia) .
- Platelet count <0.75×LLN, PT >ULN+3s, or APTT >ULN+10s .
- Organ dysfunction:
- Albumin <35 g/L (untreated) .
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Peking University First Hospital
Beijing
Cangzhou People's Hospital
Cangzhou
The First People's Hospital of Changde City
Changde
The Third Xiangya Hospital of Central South Univerdity
Changsha
Heping Hospital affiliated to Changzhi Medical College
Changzhi
Chengdu Fifth People's Hospital
Chengdu
Sichuan Provincial People's Hospital
Chengdu
Chongqing University Affiliated Fuling Central Hospital
Chongqing
Deyang People's Hospital
Deyang
The First Affiliated Hospital of Fujian Medical University
Fuzhou
The First Affiliated Hospital of Jinan University
Guangzhou
The First Affiliated Hospital Of University Of South China
Hengyang
The Second Affiliated Hospital of Jiaxing University
Jiaxing
The First People's Hospital of Lianyungang
Lianyungang
Liuzhou Worker's Hospital
Liuzhou
Mianyang Central Hospital
Mianyang
Nanjing Drum Tower Hospital
Nanjing
The Second Nanning People's Hospital
Nanning
Ningbo Medical Center LIHUILI Hospital
Ningbo
Ningbo NO.2 Hospital
Ningbo
Shanxi Bethune Hospital
Taiyuan
The First Affiliated Hospital of Wannan Medical College
Wuhu
Affiliated Hospital of Jiangnan University
Wuxi
Xi'an Honghui Hospital
Xi'an
About this study
Official title: 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
- Conditions
- Postoperative Analgesia
- Being tested
- Nalbuphine Hydrochloride Injection, Morphine Hydrochloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine Hydrochloride InjectionDrug
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
Morphine Hydrochloride InjectionDrug
PCIA，The lockout interval is set at 10 minutes, with no background infusion.
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine group | Experimental | Not described Receives: Drug: Nalbuphine Hydrochloride Injection |
| Morphine group | Active comparator | Not described Receives: Drug: Morphine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 0-48 hours
Secondary outcomes (11)
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."
Measured: 0-12 hours
Sum of Pain Intensity Difference over 0-24 hours(SPID24)
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."
Measured: 0-24 hours
Sum of Pain Intensity Difference over 0-32 hours(SPID32)
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."
Measured: 0-32 hours
Total Number of PCIA Pump attempts during 0~48h
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
Measured: 0-48 hours
Number of Effective Deliveries during 0~48h
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
Measured: 0-48 hours
Total Delivered Dose during 0~48h
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
Measured: 0-48 hours
Time to First Use of Rescue Medication
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)
Measured: 0-48 hours
Proportion of Subjects Requiring Rescue Medication
Measured: 0-48 hours
Number of Rescue Medication Administrations
Measured: 0-48 hours
Proportion of Subjects with Treatment Failure
Measured: 0-48 hours
Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose
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).
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start7 Aug 2024
- Primary completion8 Jul 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949852
- Sponsor's protocol ID
- YZJ-NBF-YZ-2303
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06949852
- Acronym / sponsor ID
- YZJ-NBF-YZ-2303
- Conditions
- Postoperative Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine group | Experimental | Drug: Nalbuphine Hydrochloride Injection |
| Morphine group | Active comparator | Drug: Morphine Hydrochloride Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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:
- Cardiovascular diseases/history:
- Respiratory disorders/history:
- Paralytic ileus, biliary/pancreatic diseases within 12 months before screening .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphine Hydrochloride InjectionPCIA，The lockout interval is set at 10 minutes, with no background infusion. | Drug | Nalbuphine group |
| Morphine Hydrochloride InjectionPCIA，The lockout interval is set at 10 minutes, with no background infusion. | Drug | Morphine group |
Primary outcome
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."
11 secondary outcomes
Sum of Pain Intensity Difference over 0-12 hours(SPID12)
Time frame: 0-12 hours
Sum of Pain Intensity Difference over 0-24 hours(SPID24)
Time frame: 0-24 hours
Sum of Pain Intensity Difference over 0-32 hours(SPID32)
Time frame: 0-32 hours
Total Number of PCIA Pump attempts during 0~48h
Time frame: 0-48 hours
Number of Effective Deliveries during 0~48h
Time frame: 0-48 hours
Total Delivered Dose during 0~48h
Time frame: 0-48 hours
Time to First Use of Rescue Medication
Time frame: 0-48 hours
Proportion of Subjects Requiring Rescue Medication
Time frame: 0-48 hours
Number of Rescue Medication Administrations
Time frame: 0-48 hours
Proportion of Subjects with Treatment Failure
Time frame: 0-48 hours
Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose
Time frame: 0-48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalbuphine Hydrochloride Injection and Morphine Hydrochloride Injection in people with Postoperative Analgesia, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Pain Intensity Difference over 0-48 hours(SPID48) (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.