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The Efficacy and Safety of Bupivacaine Liposomes in Lower Extremity Debridement Following Burn Injuries

The Efficacy and Safety of Bupivacaine Liposomes in Lower Extremity Debridement Following Burn Injuries

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110010
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Extensive burn injuries

Interventions

Bupivacaine liposome group:Bupivacaine liposome injection 266mg can be used directly
Bupivacaine group:Bupivacaine injection (0.5%, 10ml, containing 50mg of bupivacaine) was diluted with 0.9% normal saline to 20ml, with a final concentration of 0.25%

Sponsors

Chinese People's Liberation Army Northern Theater Command General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years; 2. Second- or third-degree burns on the lower limb thighs requiring surgical debridement; 3. Burn area 10%-30%; 4. ASA classification II-III; 5. Planned surgical treatment under general anesthesia; 6. Able to understand and cooperate with pain assessment; 7. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of allergy to amide local anesthetics (such as lidocaine, bupivacaine, etc.); 2. Allergy to eggs, soy, or lipid emulsions (liposomal bupivacaine contains phospholipid components); 3. Pregnant or breastfeeding women; 4. Severe mental illness, dementia, or cognitive impairment preventing cooperation with assessment; 5. Severe cardiovascular disease (NYHA class III-IV heart function, severe arrhythmia, recent myocardial infarction); 6. Severe liver dysfunction (Child-Pugh class C) or renal dysfunction (serum creatinine >200 µmol/L); 7. Coagulation disorders (PT > 1.5 times normal value or PLT < 80 × 10^9/L); 8. Infectious shock, sepsis, or multi-organ failure; 9. History of long-term opioid use (continuous use for more than 1 month); 10. Skin infection or anatomical abnormalities at the site of nerve block puncture.

Design outcomes

Primary

MeasureTime frame
QoR-15 score 48 hours after the operation;

Secondary

MeasureTime frame
The sufentanil consumption within 0-24 hours and 24-48 hours after the operation was converted to morphine milligram equivalents for comparison;

Countries

China

Contacts

Public ContactShilei Zhao

The General Hospital of the PLA Northern Theater Command

zhaoshilei_02@163.com+86 139 9827 6906

Outcome results

None listed

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