Cranial Blocks for Postoperative Anesthesia

Phase 4

Terminated

• Conditions: Craniotomy Surgery
• Interventions: Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine; Drug: Saline

• Registration Number: NCT04749797
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Results First Submitted: 2022-10-28
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• ≥18 years of age
• Need for elective supratentorial craniotomy
• Preoperative GCS > 13

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine Injection	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.
Liposomal Bupivacaine	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.
Saline group	Saline	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States