Vertebral Fracture Clinical Trial
Official title:
Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia
Verified date | February 2021 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health Mather Hospital | Port Jefferson | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-procedure Pain Score | 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. | At pre-procedure consultation. | |
Primary | Immediate Post-procedure Pain Score | 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. | In the immediate post-procedure period in recover. | |
Primary | One-week Post-procedure Pain Score | 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. | At one-week post procedure follow-up. | |
Primary | Immediate Post-procedure Satisfaction Score | 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. | Assessed at one-week post procedure follow-up. | |
Primary | One-week Post-procedure Satisfaction Score | 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. | At one-week post-procedure follow-up. | |
Secondary | Heart rate disturbance | >20% change from baseline heart rate as measured in beats per minute (BPM) | Intraprocedural | |
Secondary | Blood pressure disturbance | >20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg) | Intraprocedural | |
Secondary | Need for additional anesthesia or sedation | 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 | |
Secondary | Intraprocedural pain during balloon augmentation | 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. | Intraprocedural |
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