Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
11 participants
INTERVENTIONAL
2020-09-02
2021-07-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Saline
Used as cranial block for craniotomy surgery
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.
Bupivacaine Injection
Used as cranial block for craniotomy surgery
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.
Liposomal bupivacaine
Used as cranial block for craniotomy surgery
Interventions
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Liposomal bupivacaine
Used as cranial block for craniotomy surgery
Bupivacaine Injection
Used as cranial block for craniotomy surgery
Saline
Used as cranial block for craniotomy surgery
Eligibility Criteria
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Inclusion Criteria
* Need for elective supratentorial craniotomy
* Preoperative GCS \> 13
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Timothy Lucas, MD, PHD, MHCI
Primary Investigator
Principal Investigators
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Timothy H Lucas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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834603
Identifier Type: -
Identifier Source: org_study_id
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