Scalp nerve block with liposomal versus standard bupivacaine for post-craniotomy pain relief
A Multicenter, Single-blind, Randomized Controlled Study on the Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy
This trial will test whether adding liposomal bupivacaine to scalp nerve blocks gives longer, better pain relief than standard bupivacaine for adults after elective craniotomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07049094 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for elective supratentorial craniotomy with ASA I–III, able to give informed consent, with preoperative GCS 15 and without significant preoperative headache or contraindications to nerve block are ideal candidates.
Not a fit: Patients with severe liver, renal, or heart failure, long-term opioid or steroid use, active infection or tumor at the puncture site, cognitive impairment, recent substance abuse, or preoperative headache NRS ≥4 are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could provide longer-lasting post-craniotomy pain relief, reduce opioid use and opioid-related side effects, and help speed recovery.
How similar studies have performed: Scalp nerve blocks are an established part of multimodal analgesia after craniotomy, but use of liposomal bupivacaine for extended scalp analgesia has limited and mixed evidence in this specific setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.