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Study on the Efficacy and Safety of Liposomal Bupivacaine Injection for Postoperative Analgesia in Neurosurgery: Exploratory, Pilot (Pilot) Controlled Trial

Study on the Efficacy and Safety of Liposomal Bupivacaine Injection for Postoperative Analgesia in Neurosurgery: Exploratory, Pilot (Pilot) Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112497
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

craniocerebral surgery

Interventions

Ropivacaine group:0.5% Ropivacaine is used to scalp nerve block
Bupivacaine liposome group:0.665mg/ml of liposomal bupivacaine injection is used for scalp nerve block

Sponsors

huashan hospital fudan university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Patients scheduled for elective craniotomy neurosurgery with tumours located at or above the supraorbital notch; 3. American Society of Anesthesiologists (ASA) physical status classification I–III; 4. Patients must be conscious and able to provide informed consent preoperatively; 5. Informed consent must be signed by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to bupivacaine or similar local anaesthetics; 2. Severe respiratory, hepatic or renal impairment; 3. Coagulation disorders; 4. Mini-Mental State Examination (MMSE) score < 18; 5. Chronic headache; 6. Infection at injection site; 7. Participation in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Postoperative pain score;

Secondary

MeasureTime frame
length of stay;CRP;MAP changes during the surgery;Total consumption of opioid drugs during the operation;HR changes during the surgery;PONV;Consumption of NSAINDS ;

Countries

China

Contacts

Public ContactLi Li

huashan hospital fudan university

mazuilili@126.com+86 188 1794 6855

Outcome results

None listed

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