CompletedEarly Phase 1

Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management

United States10 participantsStarted 2020-01-10

Plain-language summary

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

Who can participate

Age range

50 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre-procedure Pain Score

Timeframe: At pre-procedure consultation.

Immediate Post-procedure Pain Score

Timeframe: In the immediate post-procedure period in recover.

One-week Post-procedure Pain Score

Timeframe: At one-week post procedure follow-up.

Immediate Post-procedure Satisfaction Score

Timeframe: Assessed at one-week post procedure follow-up.

One-week Post-procedure Satisfaction Score

Timeframe: At one-week post-procedure follow-up.

Trial details

NCT IDNCT04774029

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-01

View on ClinicalTrials.gov More Vertebral Compression trials