Cranial Blocks for Postoperative Anesthesia

University of Pennsylvania

Status and phase: Terminated; Phase 4

Conditions: Craniotomy Surgery

Treatments: Drug: Liposomal bupivacaine; Drug: Saline; Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04749797

834603

Details and patient eligibility

About

This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 3 patient groups, including a placebo group

Saline group

Placebo Comparator group

Description:

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:

Drug: Saline

Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Injection

Liposomal Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine