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Local Anesthetic

Local/MAC Anesthesia for Lumbar Spinal Stenosis

Phase < 1

Recruiting

Led By Todd Alamin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with lumbar stenosis to be decompressed over 1-3 segments

Ages 40-95

Must not have

Patients with daily morphine equivalents of 100mg or more

Planned significant nerve root retraction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up basline through year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a local anesthetic plus a light sedative is as effective as general anesthesia for some types of surgery. They will also look at patients' outcomes and experiences.

Who is the study for?

This trial is for individuals aged 40-95 with lumbar spinal stenosis needing decompression over 1-3 segments and who are suitable for general anesthesia. It excludes those unable to follow up, on high daily morphine doses, previous back fusion surgery, or allergies to eggs, soy, or propofol components.

What is being tested?

The study compares the effectiveness of local plus MAC (Monitored Anesthesia Care) anesthesia versus general anesthesia in patients undergoing lumbar decompression surgery. It aims to assess patient outcomes and experiences with these anesthetic methods.

What are the potential side effects?

Potential side effects may include reactions at the injection site from Lidocaine or Propofol such as pain or swelling, dizziness, nausea, and in rare cases more serious allergic reactions related to known sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lumbar stenosis needing surgery on 1-3 spine segments.

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I am between 40 and 95 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take 100mg or more of pain medication daily.

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I am scheduled for a procedure involving significant nerve adjustment.

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I have had a spinal fusion surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ basline through year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~basline through year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and basline through year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Oswestry Disability Index (ODI) score

Change in patient reported pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Monitored Anesthetic Care (MAC)/LocalActive Control1 Intervention

Patients under this group wil be undergoing limbar decompression surgery with Monitored Anesthetic care, (MAC)/Local. Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed.

Group II: General anesthesiaActive Control1 Intervention

Patients under this group will be undergoing lumbar decompression surgery with general anesthesia: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.

0 / 5Eligibility criteria met