The Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy
Recruiting now · Phase 4
Conditions studied: Brain Tumor Adult, Cerebrovascular Disease
In brief
After undergoing craniotomy, 60% to 84% of neurosurgery patients experience moderate to severe acute pain, primarily in the first 48 hours. This pain is mostly superficial, affecting the muscles and soft tissues around the skull. Poor pain management can lead to complications such as restlessness, nausea, hypertension, increased intracranial pressure, and prolonged recovery, potentially resulting in chronic headaches. Opioids are commonly used to manage this pain but can cause significant side effects like sedation, nausea, and increased intracranial pressure, which can mask serious conditions. Non-opioid medications and scalp infiltration techniques can help but may not provide sufficient pain relief for the duration needed. Currently, multimodal analgesia, particularly scalp nerve blocks, is advocated in neurosurgical recovery practices. These blocks are effective and simpler to perform, but the effects of long-acting local anesthetics, like bupivacaine, typically last only 24 hours. Since pain often persists longer than that, there is a need for better pain management strategies. Liposome bupivacaine is a new long-acting local anesthetic approved by the FDA, offering pain relief for up to 72 hours compared to regular bupivacaine's 8-hour duration. Its effectiveness has been confirmed in various nerve block procedures, but it has not been reported for scalp nerve blocks. This study aims to investigate whether liposome bupivacaine scalp nerve blocks can provide long-lasting postoperative pain relief, promote quicker recovery, and reduce complications in neurosurgery patients.
Key facts
- Study ID
- NCT07049094
- Run by
- Zhejiang University
- People needed
- 218
- Starts
- 2025-06-25
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-07-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- ASA I-III
- Scheduled for elective cranial surgery
- Informed consent from the patient or legal representative
You may not qualify if…
- 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
Where it is running
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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