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

Northwell Health

Status and phase: Completed; Early Phase 1

Conditions: Vertebra Compression Fracture; Vertebral Compression; Vertebral Fracture

Treatments: Drug: Lidocaine induced basivertebral nerve block; Procedure: Basivertebral nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT04774029

MTH18-017

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

BVN Block

Experimental group

Description:

Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.

Treatment:

Procedure: Basivertebral nerve block

Drug: Lidocaine induced basivertebral nerve block