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

RecruitingPhase 4Ages 18 Years - anyAllZhejiang University
NCT07049094 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 perf

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📋 Eligibility rules (as published)
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
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What it tests

  • scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution
  • scalp nerve block with 0.50% hydrochloride bupivacaine
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Where

1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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