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

NCT07049094 | Recruiting Phase 4

• 1 other identifier: ZJU2025B0536
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor Adult; Cerebrovascular Disease

Keywords

supratentorial craniotomy; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Resting Area Under the Curve - Numerical Rating Scale score within 48 hours after surgery

  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.

  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

Secondary Outcomes (7)

• Area Under the Curve - Numerical Rating Scale score during coughing within 48 hours after surgery

  within 48 hours after surgery

• Numerical Rating Scale score at rest after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Day 3

  Postoperative Day 1 to Day 3

• Numerical Rating Scale score during coughing after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Postoperative Day 3

  Postoperative Day 1 to Day 3

• Analgesic use within 48 hours after surgery

  within 48 hours after surgery

• Overall Benefit Assessment Score for Analgesia within 48 Hours after Surgery

  within 48 Hours after Surgery

Other Outcomes (3)

• Monitoring postoperative adverse events according to the Common Terminology Criteria for Adverse Events version 5.0

  postoperative day 1 to day 5

• Infection and bleeding at the puncture site

  postoperative day1 to day5

• complications of scalp nerve block (ptosis, shallow nasolabial fold, facial asymmetry, speech with air leakage, salivation)

  postoperative day1 to day5

Study Arms (2)

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

EXPERIMENTAL

In this group, patients use 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution for scalp nerve block

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

scalp nerve block with 0.50% hydrochloride bupivacaine

ACTIVE COMPARATOR

In this group, patients use 0.50% hydrochloride bupivacaine for scalp nerve block

Drug: scalp nerve block with 0.50% hydrochloride bupivacaine

Interventions

scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution DRUG

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

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

scalp nerve block with 0.50% hydrochloride bupivacaine DRUG

Using 0.50% hydrochloride bupivacaine for scalp nerve block

scalp nerve block with 0.50% hydrochloride bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Diansan Su, PhD

CONTACT

+8618616514088; diansansu@yahoo.com

Bingquan Chen, Master

CONTACT

+8615990066177; cbqa123@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 3, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (1)