NCT04774029

Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management

Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vertebral Compression
• Vertebra Compression Fracture
• Vertebral Fracture

Interventions

Type	Name	Description
PROCEDURE	Basivertebral nerve block	Temporary intraosseous basivertebral nerve block using lidocaine
DRUG	Lidocaine induced basivertebral nerve block	Intraosseous lidocaine basivertebral nerve block

Timeline

• Start date: 2020-01-10
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2021-02-26
• Last updated: 2021-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study