Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia
Overview
- Phase
- Early Phase 1
- Intervention
- Basivertebral nerve block
- Conditions
- Vertebral Compression
- Sponsor
- Northwell Health
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pre-procedure Pain Score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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.
Investigators
Eligibility 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
Arms & Interventions
BVN Block
Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.
Intervention: Basivertebral nerve block
BVN Block
Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.
Intervention: Lidocaine induced basivertebral nerve block
Outcomes
Primary Outcomes
Pre-procedure Pain Score
Time Frame: At pre-procedure consultation.
Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained upon preprocedural consultation.
Immediate Post-procedure Pain Score
Time Frame: In the immediate post-procedure period in recover.
Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained immediately post-procedure.
One-week Post-procedure Pain Score
Time Frame: At one-week post procedure follow-up.
Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained at one-week post-procedure follow-up in clinic.
Immediate Post-procedure Satisfaction Score
Time Frame: Assessed at one-week post procedure follow-up.
Patients will be asked to rate their satisfaction using a subjective Likert scale of 1 - 4, in the immediate post-procedure period during recovery. Satisfaction ratings were defined as follows: 1 = completely dissatisfied, 2 = dissatisfied, 3 = satisfied, 4 = very satisfied.
One-week Post-procedure Satisfaction Score
Time Frame: At one-week post-procedure follow-up.
Patients will be asked to rate their satisfaction using a subjective Likert scale of 1 - 4, at one week clinical follow-up. Satisfaction ratings were defined as follows: 1 = completely dissatisfied, 2 = dissatisfied, 3 = satisfied, 4 = very satisfied.
Secondary Outcomes
- Heart rate disturbance(Intraprocedural)
- Blood pressure disturbance(Intraprocedural)
- Need for additional anesthesia or sedation(Intraprocedural)
- Intraprocedural pain during balloon augmentation(Intraprocedural)