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Liposomal bupivacaine for Craniotomy Surgery
Phase 4
Waitlist Available
Led By Timothy H Lucas, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months (study terminated)
Awards & highlights
Study Summary
This trial found that adding bupivacaine or liposomal bupivacaine to the standard of care for patients undergoing craniotomies resulted in better outcomes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 months (study terminated)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months (study terminated)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analogue Scale
Secondary outcome measures
Length of Stay (ICU
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Liposomal BupivacaineExperimental Treatment1 Intervention
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.
Group II: BupivacaineActive Control1 Intervention
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.
Group III: Saline groupPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,016 Previous Clinical Trials
42,874,085 Total Patients Enrolled
Timothy H Lucas, MDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding your baby.You have had surgery on both sides of your skull.You are allergic to local numbing medicines.You had brain surgery that involved an incision outside the targeted area.You require surgery on the upper part of your brain.You are unable to understand or use a pain measurement tool called the visual analog scale (VAS).You have a known or suspected allergy to local anesthesia.You are currently taking certain medications for migraine, depression or mood disorders that may interact with the study drug.You have had a previous surgery on your scalp.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal Bupivacaine
- Group 2: Bupivacaine
- Group 3: Saline group
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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