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PI left institution
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This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline group | Placebo Comparator | 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. |
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| Bupivacaine | Active Comparator | 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. |
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| Liposomal Bupivacaine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Used as cranial block for craniotomy surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (ICU and | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy H Lucas, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
No plan at this time to share data with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Group | The surgeon will administer injectable saline as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale | 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. | Posted | Mean | Full Range | score on a scale | 10 months (study terminated prior to completion) |
|
AE data collected 72 hours post-operatively
Does not differ from clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline Group | The surgeon will administer injectable saline as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema, cerebral | Nervous system disorders | Systematic Assessment | Grade 4 edema. Participant had extensive edema prior to surgery. Post-op head CT still demonstrated cerebral edema, while ultimately required further intervention, including decompressive hemicraniectomy. |
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Study concluded before reaching subject n goal due to slow enrollment related to COVID-19 pandemic and PI leaving institution. Sample size not significant enough to accurately analyze data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Lucas | University of Pennsylvania | (215) 662-3487 | Timothy.Lucas@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Jul 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
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On the morning of the procedure, participants will be assigned sequentially to the lowest unassigned randomization number. The surgeon performing the procedure and operating room staff will not be blinded to the intervention, since they will see whether the patient is receiving liposomal bupivacaine, bupivacaine or saline. However, all providers obtaining post-operative data from the patients will be blinded as to which treatment the patient received, in addition to the patient themselves.
| Bupivacaine Injection |
| Drug |
Used as cranial block for craniotomy surgery |
|
| Saline | Drug | Used as cranial block for craniotomy surgery |
|
| BG001 | Bupivacaine | The surgeon will administer bupivacaine as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
| BG002 | Liposomal Bupivacaine | The surgeon will administer Exparel (liposomal bupivacine) as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
The surgeon will administer bupivacaine as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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
| OG001 | Saline Group | The surgeon will administer injectable saline as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
| OG002 | Liposomal Bupivacaine | The surgeon will administer Exparel (liposomal bupivacine) as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 |
|
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| Secondary | Length of Stay (ICU and | 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. | Posted | Mean | Full Range | Days | 10 months (study terminated) |
|
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| 0 |
| 3 |
| EG001 | Bupivacaine | The surgeon will administer bupivacaine as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 | 0 | 4 | 1 | 4 | 0 | 4 |
| EG002 | Liposomal Bupivacaine | The surgeon will administer Exparel (liposomal bupivacine) as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 | 0 | 4 | 0 | 4 | 0 | 4 |
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| Transient ischemic attack | Nervous system disorders | Systematic Assessment | Subject experienced a TIA post-operatively. Symptoms resolved within the same day. |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
|