Craniotomy Surgery
Conditions
Keywords
craniotomy
Brief summary
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
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.
Interventions
DRUGLiposomal bupivacaine
Used as cranial block for craniotomy surgery
DRUGBupivacaine Injection
Used as cranial block for craniotomy surgery
DRUGSaline
Used as cranial block for craniotomy surgery
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (ICU and | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| 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 | 4 |
| 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 | 4 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not meet I/E criteria after surgery | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Saline Group | Bupivacaine | Liposomal Bupivacaine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 3 | 1 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 10 months (study terminated prior to completion)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine | Visual Analogue Scale | 4.5 score on a scale |
| Saline Group | Visual Analogue Scale | 3 score on a scale |
| Liposomal Bupivacaine | Visual Analogue Scale | 4.25 score on a scale |
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.
Time frame: 10 months (study terminated)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivacaine | Length of Stay (ICU and | Hospital Stay | 4.25 Days |
| Bupivacaine | Length of Stay (ICU and | ICU Stay | .94 Days |
| Saline Group | Length of Stay (ICU and | Hospital Stay | 2.5 Days |
| Saline Group | Length of Stay (ICU and | ICU Stay | .97 Days |
| Liposomal Bupivacaine | Length of Stay (ICU and | Hospital Stay | 6.5 Days |
| Liposomal Bupivacaine | Length of Stay (ICU and | ICU Stay | 1.09 Days |