Vertebra Compression Fracture, Vertebral Compression, Vertebral Fracture
Conditions
Keywords
Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture
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.
Interventions
PROCEDUREBasivertebral nerve block
Temporary intraosseous basivertebral nerve block using lidocaine
DRUGLidocaine induced basivertebral nerve block
Intraosseous lidocaine basivertebral nerve block
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-week Post-procedure Satisfaction Score | 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. |
| Pre-procedure Pain Score | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure disturbance | Intraprocedural | \>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg) |
| Need for additional anesthesia or sedation | Intraprocedural | Intraprocedural monitoring for patient pain in real time during the procedure. Need for additional pain or sedative medication such as Fentanyl or Versed, at the discretion of the interventional radiologist performing the procedure. |
| Intraprocedural pain during balloon augmentation | Intraprocedural | Special attention to patient pain will be assessed during intraprocedural balloon augmentation, as this is often the most painful part of the procedure. 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. Additional routine monitoring of pain will take place during the procedure as carried out by the circulating nurse and by the interventional radiologist performing the procedure. |
| Heart rate disturbance | Intraprocedural | \>20% change from baseline heart rate as measured in beats per minute (BPM) |
Countries
United States
Outcome results
None listed