Scalp nerve block with liposomal versus standard bupivacaine for post-craniotomy pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, controlled Phase 4 trial at Zhejiang University compares standard hydrochloride bupivacaine scalp nerve blocks with a combination that includes liposomal bupivacaine in adults undergoing elective cranial surgery. Eligible patients are randomized to receive either standard bupivacaine or bupivacaine plus liposomal formulation, with clinicians aware of allocation and patients blinded. Outcomes include postoperative pain scores, opioid consumption, recovery quality, and complications, with thorough preoperative neurological and laboratory assessments. The protocol uses validated pain scales and standardized scalp nerve block techniques to measure analgesic duration and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Diansan Su, PhD
• Email: diansansu@yahoo.com
• Phone: +8618616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.