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New painkiller nalbuphine takes on morphine in Post-Surgery trial

NCT ID NCT06949852

Symptom relief Sponsor: Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether nalbuphine, a painkiller, works as well as morphine for pain after surgery. 289 adults having abdominal or orthopedic surgery received either drug through a pump they could control. Researchers measured pain intensity differences over 48 hours to compare effectiveness and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nalbuphine (a painkiller)
What this could lead to
If it works, this could offer a new option for managing pain after surgery with possibly fewer side effects than morphine.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Nalbuphine may not be more effective or safer than morphine for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

289 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative analgesia

Contacts and locations

Locations

  • Affiliated Hospital of Jiangnan University

    Wuxi, China

  • Cangzhou People's Hospital

    Cangzhou, China

  • Chengdu Fifth People's Hospital

    Chengdu, China

  • Chongqing University Affiliated Fuling Central Hospital

    Chongqing, China

  • Deyang People's Hospital

    Deyang, China

  • Heping Hospital affiliated to Changzhi Medical College

    Changzhi, China

  • Liuzhou Worker's Hospital

    Liuzhou, China

  • Mianyang Central Hospital

    Mianyang, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Ningbo Medical Center LIHUILI Hospital

    Ningbo, China

  • Ningbo NO.2 Hospital

    Ningbo, China

  • Peking University First Hospital

    Beijing, China

  • Shanxi Bethune Hospital

    Taiyuan, China

  • Sichuan Provincial People's Hospital

    Chengdu, China

  • The First Affiliated Hospital Of University Of South China

    Hengyang, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, China

  • The First Affiliated Hospital of Jinan University

    Guangzhou, China

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, China

  • The First People's Hospital of Changde City

    Changde, China

  • The First People's Hospital of Lianyungang

    Lianyungang, China

  • The Second Affiliated Hospital of Jiaxing University

    Jiaxing, China

  • The Second Nanning People's Hospital

    Nanning, China

  • The Third Xiangya Hospital of Central South Univerdity

    Changsha, China

  • Xi'an Honghui Hospital

    Xi'an, China

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