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

Condition(s) studied

Investigational drug(s) / intervention(s)

scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution: Using 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution for scalp nerve block

scalp nerve block with 0.50% hydrochloride bupivacaine: Using 0.50% hydrochloride bupivacaine for scalp nerve block

Study summary

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.

Eligibility

Primary outcome measure(s)

• Resting Area Under the Curve - Numerical Rating Scale score within 48 hours after surgery — 2 hours post-operation, 4 hours post-operation, 8 hours post-operation, postoperative day 1 8:30, postoperative day 12:00, postoperative day 1 16:00
  The Numerical Rating Scale (NRS) is a widely used tool for assessing the intensity of pain. It is a self-reported scale where patients are asked to rate their pain on a numerical scale ranging from 0 to 10. Minimum Value (0): Indicates "No Pain" or the complete absence of pain. This is the best possible outcome for the patient. Maximum Value (10): Indicates "Worst Pain Imaginable" or the most severe pain the patient can conceive. This is the worst possible outcome for the patient.

Trial sites (1)

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