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

Completed · Early Phase 1

Conditions studied: Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture

In brief

The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.

Key facts

Study ID

NCT04774029

Run by

Northwell Health

People needed

10

Starts

2020-01-10

Expected to finish

2020-05-01

Last updated by the study team

2021-02-26

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwell Health Mather Hospital — Port Jefferson, New York, United States

Full record on ClinicalTrials.gov

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