The Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy

Launched by ZHEJIANG UNIVERSITY · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain after brain surgery called a craniotomy. Many patients experience moderate to severe pain in the first two days after surgery, mainly around the muscles and soft tissues of the scalp. This pain can be hard to control and, if not managed well, might cause problems like restlessness, nausea, high blood pressure, or even longer recovery times. The study is testing whether a special long-lasting numbing medicine called liposome bupivacaine, given as a scalp nerve block (an injection that numbs specific nerves in the scalp), can reduce pain for up to 72 hours after surgery, helping patients recover more comfortably and quickly.

Adults aged 18 and older who are scheduled for planned brain surgery and meet certain health criteria may be eligible to join. Participants will receive either the new long-lasting nerve block or the usual care to see which works better for pain relief. The study excludes people with certain health issues like severe liver or kidney problems, allergies to local anesthetics, ongoing opioid use, or those who cannot understand pain rating tools. If you join, you can expect close monitoring of your pain and recovery after surgery, with the goal of improving comfort and reducing complications. This trial is currently recruiting patients who fit the criteria and are willing to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • ASA I-III
• • Scheduled for elective cranial surgery
• • Informed consent from the patient or legal representative
• Exclusion Criteria:
• • Preoperative Glasgow score \< 15
• • Preoperative headache with NRS ≥ 4
• • Anticipated postoperative sedation or extubation difficulties requiring mechanical ventilation
• • Inability to understand the numerical rating scale (NRS)
• • Allergies or contraindications to amide local anesthetics, opioids, or NSAIDs
• • Long-term opioid or corticosteroid treatment (\> 2 weeks)
• • History of drug abuse in the past 2 years
• • Daily alcohol consumption exceeding 3 standard doses
• • Mental or cognitive disorders affecting perioperative assessment
• • Contraindications for nerve blocks, including infection or tumors at the puncture site, diagnosed diabetic peripheral neuropathy, or inability to cooperate
• • Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis preoperatively), or severe heart failure (METS \< 4)
• • Pregnant or breastfeeding women
• • History of craniotomy or pre-existing pathological pain conditions (e.g., migraines, trigeminal neuralgia)
• • Incisions for craniotomy extending beyond the area covered by the scalp nerve blocks
• • Participation in other clinical trials