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A Single-Center, Single-Blind, Randomized Controlled Study on the Analgesic Effect of Scalp Nerve Block with Liposomal Bupivacaine After Craniotomy

A Single-Center, Single-Blind, Randomized Controlled Study on the Analgesic Effect of Scalp Nerve Block with Liposomal Bupivacaine After Craniotomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124916
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Acute pain after craniotomy

Interventions

Control group:Scalp nerve block with 0.5% bupivacaine hydrochloride
Experimental group:Scalp nerve block with 0.25% bupivacaine hydrochloride combined with 0.67% liposomal bupivacaine

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and <= 75 years; 2. American Society of Anesthesiologists (ASA) physical status classification ?~?; 3. Scheduled for supratentorial craniotomy; 4. Informed consent obtained from the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Preoperative Glasgow Coma Scale (GCS) score < 15; 2. Predicted to require sedation, unable to extubate, or at high risk of extubation difficulty requiring mechanical ventilation support postoperatively; 3. Unable to understand the Quality of Recovery-15 (QoR-15) scale and Numerical Rating Scale (NRS) for pain assessment; 4. History of allergy or contraindication to amide local anesthetics, opioids, or non-steroidal anti-inflammatory drugs (NSAIDs); 5. Long-term treatment with opioids or corticosteroids for more than 2 weeks; 6. History of drug abuse or addiction within the past 2 years; 7. Daily alcohol consumption exceeding 3 standard doses (˜10g alcohol, equivalent to 50g Chinese high-alcohol liquor); 8. Presence of mental or cognitive disorders that may interfere with perioperative assessment; 9. Contraindications to nerve block, including infection or tumor at the puncture site, confirmed diabetic peripheral neuropathy, and inability to cooperate; 10. Patients with severe liver insufficiency (Child-Pugh Class C), severe renal insufficiency (requiring dialysis before surgery), or severe heart failure (METS < 4); 11. Pregnant or lactating women; 12. Craniotomy incision beyond the area covered by scalp nerve block; 13. Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Quality of Recovery-15 (QoR-15) score assessed at 48 hours after surgery;

Secondary

MeasureTime frame
Usage of analgesics;Nausea and vomiting incidence rate;

Countries

China

Contacts

Public ContactXin Jihua

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

8570@renji.com+86 21 68383364

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026