Status:
COMPLETED
Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management
Lead Sponsor:
Northwell Health
Conditions:
Vertebral Compression
Vertebra Compression Fracture
Eligibility:
All Genders
50-100 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04774029
Start Date
January 10 2020
End Date
May 1 2020
Last Update
February 26 2021
Active Locations (1)
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1
Northwell Health Mather Hospital
Port Jefferson, New York, United States, 11777