RecruitingPhase 4NCT07049094

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

A Multicenter, Single-blind, Randomized Controlled Study on the Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy


Sponsor

Zhejiang University

Enrollment

218 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting a long-acting local anesthetic (bupivacaine liposomes) around the nerves of the scalp can reduce pain after brain surgery (craniotomy). Researchers want to see if this nerve block technique improves pain control compared to standard care. **You may be eligible if:** - You are 18 or older - You are scheduled for a planned (non-emergency) brain surgery - You are otherwise in good to moderate general health (ASA class I–III) - You are able to rate your pain on a numeric scale **You may NOT be eligible if:** - You have a low level of consciousness before surgery - You already have significant headaches before surgery - You are allergic to local anesthetics, opioids, or anti-inflammatory drugs - You have a history of drug or alcohol abuse - You have severe liver, kidney, or heart problems - You have had previous brain surgery or a pre-existing chronic pain condition affecting the head - You are pregnant or breastfeeding - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGscalp 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

DRUGscalp nerve block with 0.50% hydrochloride bupivacaine

Using 0.50% hydrochloride bupivacaine for scalp nerve block


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07049094


Related Trials