Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07049094

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

Led by Zhejiang University · Updated on 2025-07-03

218

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ASA classification I to III
  • Scheduled for elective cranial surgery
  • Provided informed consent or legal representative consent
Not Eligible

You will not qualify if you...

  • Preoperative Glasgow Coma Scale score less than 15
  • Preoperative headache with pain score 4 or higher
  • Expected postoperative sedation or extubation difficulties requiring mechanical ventilation
  • Unable to understand the Numerical Rating Scale for pain
  • Allergies or contraindications to amide local anesthetics, opioids, or NSAIDs
  • Long-term opioid or corticosteroid treatment exceeding 2 weeks
  • History of drug abuse in the past 2 years
  • Daily alcohol intake over 3 standard drinks
  • Mental or cognitive disorders affecting assessment
  • Contraindications for nerve blocks such as infection, tumors at puncture site, diabetic neuropathy, or inability to cooperate
  • Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction requiring dialysis, or severe heart failure (METS less than 4)
  • Pregnant or breastfeeding women
  • History of craniotomy or existing pathological pain conditions like migraines or trigeminal neuralgia
  • Craniotomy incisions extending beyond the area covered by scalp nerve blocks
  • Participation in other clinical trials

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

D

Diansan Su, PhD

CONTACT

B

Bingquan Chen, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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