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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04774029
Other study ID # MTH18-017
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date January 10, 2020
Est. completion date May 1, 2020

Study information

Verified date February 2021
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Basivertebral nerve block
Temporary intraosseous basivertebral nerve block using lidocaine
Drug:
Lidocaine induced basivertebral nerve block
Intraosseous lidocaine basivertebral nerve block

Locations

Country Name City State
United States Northwell Health Mather Hospital Port Jefferson New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

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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