Overview

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

Status:
Completed
Trial end date:
2020-05-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwell Health
Treatments:
Lidocaine
Criteria
Inclusion Criteria:

- Age >50 years old

- Patient must have a diagnosis of osteoporosis on dual energy x-ray absorptiometry
(DEXA),

- Patient must have an acute or subacute single level vertebral compression fracture
between T10 - L3 as confirmed via magnetic resonance imaging (MRI) or nuclear medicine
bone scan,

- Patient must have an initial pain score of greater than or equal to five using a
standard 0-10 Visual Analog Scale subjective pain score upon initial consultation.

Exclusion Criteria:

- Pathologic compression fracture, such as due to metastatic disease

- Age >90 years old or <50 years old

- Pregnancy

- Diagnosed Anxiety Disorder

- Diagnosed Depression Disorder

- Diagnosed Psychotic Disorder

- Diagnosed Mental Disease Disorder

- Diagnosed Parkinson's disease/other movement disorders/or cerebellar dysfunction

- Eastern Cooperative Oncology Group (ECOG) score at baseline prior to compression
fracture >1

- Back Pain scores at time of initial consult <5, using a standard Visual Analog Scale

- Illicit drug dependence or abuse

- Alcohol dependence or abuse