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