Cranial Blocks for Postoperative Anesthesia

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

NCT04749797•University of Pennsylvania

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+3 more criteria

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 2, 2020

Primary Completion Date

July 20, 2021

Completion Date

July 20, 2021

Last Updated

September 13, 2023

Enrollment

ACTUAL participants

Conditions

Craniotomy Surgery

Interventions

Liposomal bupivacaine

DRUG

Bupivacaine Injection

DRUG

Saline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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