Cranial Blocks for Postoperative Anesthesia

August 29, 2023 updated by: Timothy Lucas, MD, PHD, MHCI, University of Pennsylvania

Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage

This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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

Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.

The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.

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 (Actual)

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.
11

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.
  • Phase 4

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years of age
  • Need for elective supratentorial craniotomy
  • Preoperative GCS > 13

Exclusion Criteria:

  • Preoperative GCS ≤ 13
  • Child (<18 years of age)
  • Inability to understand or use the visual analog scale (VAS)
  • Proven or suspected allergy to local anesthetics
  • Craniotomy incision extending beyond the field of the block
  • Patients chronically (more than 2 wk) treated with narcotic medications
  • Previous scalp incision
  • Bilateral craniotomies
  • Allergies to local anesthetics
  • GCS verbal score < 4 after extubation
  • Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
  • Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
  • Lactating Mothers

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.
Placebo Comparator: Saline group
The surgeon will administer injectable saline as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
Drug: Saline
Used as cranial block for craniotomy surgery
Active Comparator: Bupivacaine
The surgeon will administer bupivacaine as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
Drug: Bupivacaine Injection
Used as cranial block for craniotomy surgery
Experimental: Liposomal Bupivacaine
The surgeon will administer Exparel (liposomal bupivacine) as a cranial block. 20 mL of Exparel will be diluted with saline to constitute 60 mL total. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
Drug: Liposomal bupivacaine
Used as cranial block for craniotomy surgery

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
Visual Analogue Scale
Time Frame: 10 months (study terminated prior to completion)

The Visual Analogue Scale (VAS) is a straight, horizontal line of fixed length, numbered 0 to 10 as a measure of pain severity. The ends are the extreme limits of this scale, with the left side (0) representing the best outcome (no pain), and the right side (10) representing the worst outcome, extreme pain. The other numbers in between are representations of the variation in pain between these two feelings. The scale is presented to the participant with a verbal explanation of its meaning, and the participant points to or states a number indicating where they feel their pain level is best represented on the scale. That number is recorded.

For each group, every participant reported several different pain scores over multiple hours. The averages (means) below represent the summation of all of the pain scores reported throughout their admission.
10 months (study terminated prior to completion)

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
Length of Stay (ICU and
Time Frame: 10 months (study terminated)
The secondary outcome variables are the duration of stay in the intensive care unit (ICU), and the duration of time in the hospital until discharge.
10 months (study terminated)

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.
University of Pennsylvania

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.
  • Principal Investigator: Timothy H Lucas, MD, University of Pennsylvania

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.
September 2, 2020

Primary Completion (Actual)

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.
July 20, 2021

Study Completion (Actual)

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.
July 20, 2021

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 11, 2021

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.
February 8, 2021

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.
February 11, 2021

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.
September 13, 2023

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.
August 29, 2023

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, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 834603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No plan at this time to share data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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