Cranial Blocks for Postoperative Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Craniotomy Surgery

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Injection
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline group<br>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<br>* Used as cranial block for craniotomy surgery<br>|
| Active Comparator: Bupivacaine<br>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<br>* Used as cranial block for craniotomy surgery<br>|
| Experimental: Liposomal Bupivacaine<br>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<br>* Used as cranial block for craniotomy surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craniotomy