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The efficacy and safety of Nalbuphine Hydrochloride Injection in the treatment of postoperative pain after day surgery: a multicenter, randomized, parallel, and positive controlled clinical study

The efficacy and safety of Nalbuphine Hydrochloride Injection in the treatment of postoperative pain after day surgery: a multicenter, randomized, parallel, and positive controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16010032
Enrollment
Unknown
Registered
2016-11-28
Start date
2016-12-01
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

Pain after day surgery

Interventions

control group:Tramadol

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged 18 years to 50 years old, male and female; ASA I-II; breast surgery (non-radical mastectomy), thyroid surgery, hysteroscopic surgery, laparoscopic cholecystectomy, operation time 3 points. ICF was signed. BMI 18 to 29.

Exclusion criteria

Exclusion criteria: The patients known to allergy to the main drug or any kind of excipient,or known to allergy to opioids.Acute (slow) alcoholism, a history of neurological diseases. A history of chronic pain. Drug addiction and alcoholism. Paralytic ileus. Increased intracranial pressure or head injury.A history of Long-term use of opioids. Hypotension, hypothyroidism, asthma (avoid use during episodes). Prostatic hypertrophy and epilepsy patients. Taking monoamine oxidase inhibitors or antidepressants in 15 days. Preoperative liver and kidney function: ALT,AST,BUN,Cr abnormalities(ALT and AST greater than 1.5 times the upper limit of normal, BUN and Cr higher than the upper limit of normal).Coronary heart disease, bronchial asthma, poorly controlled or very difficult to control hypertension: SBP=160mmHg or DBP=100mmHg. Respiratory insufficiency, respiratory failure.Patients can not properly express wishes. Poor compliance, cant complete the trial according to the study protocol. Participated in the other tries in 30 days.Pregnant women, maternal, pregnancy test positive women of childbearing age.Coagulation dysfunction. The patients whom investigators did not consider appropriate to participate the trial.

Design outcomes

Primary

MeasureTime frame
VAS scores;Analgesia effectiveness;

Secondary

MeasureTime frame
blood pressure;Respiratory rate;heart rate;

Countries

China

Contacts

Public ContactGuo Qulian

Xiangya Hospital, Central South University

qulianguo@hotmail.com+86 0731-84327413

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026