Efficacy of Liposomal Bupivacaine Scalp Nerve Block for Postoperative Pain Management After Supratentorial Craniotomy

NCT07344181 | Active Not Recruiting DMC

• 1 other identifier: KY2025-005-02
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled trial conducted at Beijing Tiantan Hospital to evaluate the efficacy and safety of liposomal bupivacaine for scalp nerve block in managing postoperative pain after elective supratentorial craniotomy. A total of 118 eligible patients (aged 18-64, ASA I-III) will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will receive a scalp nerve block using liposomal bupivacaine. The control group will receive a scalp nerve block using standard 0.5% bupivacaine. All patients will undergo standardized general anesthesia. The primary outcome is postoperative pain intensity, measured by the Numerical Rating Scale (NRS) at multiple time points: 2, 12, 24, 48, and 72 hours after surgery. Secondary outcomes include the Glasgow Coma Scale (GCS) score, patient satisfaction, cumulative opioid consumption, and the incidence of adverse events. The study aims to determine if a single administration of liposomal bupivacaine provides superior and prolonged analgesia compared to conventional bupivacaine, potentially improving pain management and recovery for craniotomy patients. The study duration is from October 2024 to May 2027.

Conditions

Postoperative Care

Keywords

Scalp nerve blocks，acute postoperative pain，Liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• NRS pain scores

  NRS pain scores at 2, 12, 24, 48, and 72 hours postoperatively.

  2, 12, 24, 48, and 72 hours postoperatively

Secondary Outcomes (1)

• Opioid consumption

  2, 12, 24, 48, and 72 hours postoperatively.

Study Arms (2)

intervention group

EXPERIMENTAL

Preoperative scalp nerve block with liposomal bupivacaine.

Procedure: Preoperative scalp nerve block

Control Group

ACTIVE COMPARATOR

Preoperative scalp nerve block with 0.5% bupivacaine.

Procedure: Preoperative scalp nerve block

Interventions

Preoperative scalp nerve block PROCEDURE

Block of the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.

Control Group; intervention group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-64 years.
• Scheduled for elective supratentorial craniotomy under general anesthesia.
• ASA physical status I-III.
• Preoperative GCS score of 15.
• Ability to provide informed consent.

You may not qualify if:

• Chronic pain syndromes, opioid tolerance, or psychiatric disorders.
• Coagulopathy or infection at the block site.
• Allergy to local anesthetics.
• BMI \<15 or \>35.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

Location

Study Officials

• Fang Luo

  Beijing Tiantan Hospital, Capital Medical University,Beijing, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Tiantan Hospital

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified IPD and supporting documents will become available starting 6 months after the publication of the primary trial results . The data will be accessible for a period of 5 years. This timeframe aligns with standard data sharing policies to ensure data are available while the research remains relevant.
• Access Criteria: Who can access the IPD: Qualified researchers with a sound scientific proposal. What data will be accessible: De-identified individual participant data and the study protocol. How to access it: Proposals should be submitted to the corresponding author. Approved requestors will need to sign a data access agreement before gaining access via a secure file-sharing service.

Locations

CN (1)