Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774029
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2021-02-17
Brief Title:
Basivertebral Nerve Block During Vertebral Augmentation An Alternative Approach to Intraprocedural Pain Management
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures
Detailed Description:
Vertebral compression fractures secondary to osteoporosis can be treated with vertebral augmentation Since intraprocedural pain is common during vertebral body endplate manipulation these procedures are often carried out using conscious sedation or general anesthesia Research has shown that the vertebral endplates are innervated by the basivertebral nerve which has been successfully targeted via radiofrequency ablation to treat chronic vertebrogenic lower back pain With this physiology in mind the investigators will attempt to treated participants with vertebral compression using lidocaine-induced intraosseous basivertebral nerve block as the primary intraprocedural analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None