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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• ASA I-III

• Scheduled for elective cranial surgery

• Informed consent from the patient or legal representative

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Diansan Su, PhD
diansansu@yahoo.com
+8618616514088
Backup
Bingquan Chen, Master
cbqa123@zju.edu.cn
+8615990066177
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 218
Treatments
Experimental: scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution
In this group, patients use 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution for scalp nerve block
Active_comparator: scalp nerve block with 0.50% hydrochloride bupivacaine
In this group, patients use 0.50% hydrochloride bupivacaine for scalp nerve block
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov