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

January 7, 2026 updated by: Fang Luo, Beijing Tiantan Hospital

Efficacy of Liposomal Bupivacaine Scalp Nerve Block for Postoperative Pain Management After Supratentorial Craniotomy：a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Background and Rationale:

    Postoperative pain following supratentorial craniotomy is a significant clinical concern, often requiring opioid-based analgesia. However, opioid use in neurosurgical patients is limited by side effects such as sedation, respiratory depression, and nausea, which can obscure neurological assessment and delay recovery. Scalp nerve blocks (SNBs) with local anesthetics like bupivacaine are a well-established component of multimodal analgesia for craniotomy, targeting the primary sources of postoperative pain-the pericranial muscles and scalp tissues. While effective, conventional bupivacaine provides analgesia for only up to 6-8 hours, leaving patients with inadequate pain control during the critical 72-hour postoperative period.

    Liposomal bupivacaine (LB) is an extended-release formulation designed to provide sustained analgesia for up to 72 hours. Its efficacy has been demonstrated in various surgical settings, but its application in neurosurgery, particularly for scalp nerve blocks, remains underexplored. This study aims to investigate whether a single preoperative scalp nerve block with liposomal bupivacaine can provide superior and prolonged analgesia compared to standard bupivacaine, thereby reducing opioid consumption and improving patient outcomes following craniotomy.

  2. Objectives:

    Primary Objective: To compare the efficacy of liposomal bupivacaine versus standard bupivacaine for scalp nerve blocks in controlling postoperative pain, as measured by the Numerical Rating Scale (NRS) at 2, 12, 24, 48, and 72 hours after surgery.

    Secondary Objectives:

    To assess differences in cumulative opioid consumption postoperatively.

    To evaluate patient satisfaction using a standardized satisfaction scale.

    To monitor neurological status using the Glasgow Coma Scale (GCS).

    To record the incidence of adverse events (e.g., infection, hematoma, neurological deficits).

  3. Study Design:

    Design: Prospective, single-center, randomized, controlled, parallel-group trial.

    Randomization: Eligible participants will be randomized in a 1:1 ratio to either the intervention group (liposomal bupivacaine) or the control group (standard 0.5% bupivacaine). Randomization will be performed using a computer-generated sequence.

    Blinding: Outcome assessors and data analysts will be blinded to group assignments. Due to the nature of the intervention, treating clinicians will not be blinded.

  4. Participants:

    Inclusion Criteria:

    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.

    Exclusion Criteria:

    Chronic pain syndromes, opioid tolerance, or psychiatric disorders.

    Coagulopathy or infection at the block site.

    Allergy to local anesthetics.

    BMI <15 or >35.

  5. Interventions:

    Intervention Group: Preoperative scalp nerve block with liposomal bupivacaine.

    Control Group: Preoperative scalp nerve block with 0.5% bupivacaine.

    Both groups will receive standardized general anesthesia and postoperative analgesia, including rescue opioids.

  6. Outcome Measures:

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

    Secondary Outcomes:

    Opioid consumption (morphine equivalents).

    Patient satisfaction scores (5-point Likert scale).

    GCS scores.

    Adverse events related to the block or study drugs.

  7. Sample Size:

    A total of 118 participants (59 per group) will be enrolled, accounting for a 20% dropout rate. This provides 90% power to detect a 25% difference in analgesia duration at a 5% significance level.

  8. Statistical Analysis:

Data will be analyzed using SPSS v25.0. Continuous variables will be compared using t-tests or Mann-Whitney U tests; categorical variables will be analyzed with chi-square or Fisher's exact tests. Repeated-measures ANOVA will assess pain scores over time. A p-value <0.05 will be considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Chronic pain syndromes, opioid tolerance, or psychiatric disorders.

Coagulopathy or infection at the block site.

Allergy to local anesthetics.

BMI <15 or >35.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention group
Preoperative scalp nerve block with liposomal bupivacaine.
Procedure: Preoperative scalp nerve block
Block of the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.
Active Comparator: Control Group
Preoperative scalp nerve block with 0.5% bupivacaine.
Procedure: Preoperative scalp nerve block
Block of the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NRS pain scores
Time Frame: 2, 12, 24, 48, and 72 hours postoperatively
NRS pain scores at 2, 12, 24, 48, and 72 hours postoperatively.
2, 12, 24, 48, and 72 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 2, 12, 24, 48, and 72 hours postoperatively.
Opioid consumption (morphine equivalents)
2, 12, 24, 48, and 72 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fang Luo, Beijing Tiantan Hospital, Capital Medical University,Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-005-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in this article will be shared following publication. The data will be available with researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to the corresponding author. Data requestors will need to sign a data access agreement to gain access.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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