Philadelphia, Pennsylvania 19104

  • Craniotomy Surgery

Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT04749797


Primary Contact:

Principal Investigator
Timothy H Lucas, MD
University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 13, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.