An Early Phase 1 interventional study of Basivertebral nerve block and Lidocaine induced basivertebral nerve block in Vertebral Compression, Vertebra Compression Fracture and Vertebral Fracture, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-02-26.
Sponsored by Northwell Health · Early Phase 1, Interventional, and Supportive care
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.
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.
144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.
This study's enrollment of 10 is below the median of 85 across 85 interventional studies indexed under Spinal Fractures.
Browse Spinal Fractures studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.
Procedure: Basivertebral nerve block · Drug: Lidocaine induced basivertebral nerve block
Temporary intraosseous basivertebral nerve block using lidocaine
Also known as: BVN block during vertebral augmentation
Intraosseous lidocaine basivertebral nerve block
Also known as: Lidocaine BVN block
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.
Time frame: At pre-procedure consultation.
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.
Time frame: In the immediate post-procedure period in recover.
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.
Time frame: At one-week post procedure follow-up.
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.
Time frame: Assessed at one-week post procedure follow-up.
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.
Time frame: At one-week post-procedure follow-up.
Heart rate disturbance
\>20% change from baseline heart rate as measured in beats per minute (BPM)
Time frame: Intraprocedural
Blood pressure disturbance
\>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)
Time frame: Intraprocedural
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.
Time frame: Intraprocedural
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.
Time frame: Intraprocedural
Plan to share: No — Data will be made available upon request at the discretion of the primary investigator.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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