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Efficacy and safety of nalbuphine hydrochloride injection in perioperative analgesia during tumor ablation surgey: a randomized, positive control, multicentre clinical study

Efficacy and safety of nalbuphine hydrochloride injection in perioperative analgesia during tumor ablation surgey: a randomized, positive control, multicentre clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049250
Enrollment
Unknown
Registered
2021-07-28
Start date
2021-07-29
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group:Nalbuphine Hydrochloride Injection
Control group:Morphine Hydrochloride Injection

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed by clinicians as requiring tumor ablation; 2. Voluntarily participate and sign the informed consent; 3. Aged 18-80 years, gender is not limited.

Exclusion criteria

Exclusion criteria: 1. Allergic to contrast agent, test drug or other ingredients in the drug; 2. With history of substance abuse, chronic pain and mental illness; 3. Use of a monoamine oxidase inhibitor within 14 days prior to randomization; 4. Pregnant and lactating patients and those who cannot tolerate the operation due to other reasons; 5. Patients who cannot express their wishes correctly, with poor compliance, unable to complete the test according to the study protocol; 6. Participated in other drug trials within 30 days prior to enrollment; 7. Those who are judged by the researcher to be unsuitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Effective analgesic ratio;

Secondary

MeasureTime frame
Pain intensity assessment;Evaluation of analgesia satisfaction;Duration of operation;Postoperative hospital stay;Average daily dosage;Percentage of patients who did not complain of pain and completed surgery without interruption;Patient quality of life assessment;

Countries

China

Contacts

Public ContactTeng Gaojun

Zhongda Hospital Southeast University

gjteng@seu.edu.cn+86 13805171500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026