Clinical study for perioperative analgesia of nabulphine hydrochloride injection in intervertebral foramen microscopy

A multicenter, randomized, open, parallel, and positive controlled trial for the analgesic efficacy of nalbuphine hydrochloride injection in the perioperative of intervertebral foramen microscopy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800019920

Enrollment

Unknown

Registered

2018-12-08

Start date

2018-12-01

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Lumbar disc herniation

Interventions

Experimental group, negative control group, positive control group:Prophylactic analgesia

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-55 years old male and female; 2. ASA classification I or II ; 3. For patients with lumbar 4/5 intervertebral disc herniation alone (unilateral symptoms), the grade of lesion segment intervertebral disc degeneration: Pfirrmann grade is less than or equal to grade 4; Facet joint grading: Weishaupt grading is no more than 2; Preoperative lower back pain (VAS 3>) or leg pain (VAS > 5) had not been treated by surgery; 4. Voluntarily participated in and signed the informed consent; 5. BMI less than or equal to 29.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to the main drug or any adjuvant in this product, and those with a history of opioid drug allergy; 2. Acute (slow) alcoholism with a history of neurological diseases;History of chronic pain;Drug addiction and alcohol abuse; 3. Lumbar fracture, slip, deformity, infection and malignant tumor; 4. Patients with abnormal liver function; 5. Long-term history of opioid use; 6. Pregnant and lactating women and those who cannot tolerate surgery for other reasons; 7. Take monoamine oxidase inhibitors or antidepressants within 15 days; 8. Respiratory insufficiency, respiratory failure; 9. Patients who cannot express their intention correctly;Poor compliance, unable to complete the researchers according to the research scheme; 10. Participated in other drug trials within 30 days before inclusion; 11. Patients with mental illness; 12. Patients with renal dysfunction; 13. The investigator considers it inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
VAS scores;	—

Countries

China

Contacts

Public ContactQingchu Li

The Third Affiliated Hospital Of Southern Medical University

Lqc16@263.net+86 18680225370

Outcome results

None listed

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