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Local Anesthetic

Local/MAC Anesthesia for Lumbar Spinal Stenosis

Q: Who meets the requirements to join this experiment?

The trial is seeking out 100 individuals with spine stenosis between 40-95 years of age. Specifically, patients will need to have lumbar decompression surgery over 1-3 segments.

Q: How many volunteers are taking part in this medical experiment?

Affirmative. As highlighted on clinicaltrials.gov, this medical trial commenced recruiting participants in December 2021 and is still ongoing; the last update to the listing was made in May 2022. The recruitment goal of 100 patients needs to be met across 3 locations.

Q: Does the protocol for this investigation include individuals who are of advanced age?

This trial has set the age requirement for participation between 40 and 95 years old. For those who are below 18 or above 65, there are 23 studies and 231 studies respectively open to them as an alternative.

Q: Are there still opportunities to enroll in the research project?

Clinicaltrials.gov verifies that this investigation is currently recruiting subjects, with the original post dated December 1st 2021 and the most recent update being May 5th 2022.

Q: Could you provide a comprehensive overview of the research conducted previously concerning Monitored Anesthetic Care/Local?

Presently, there are 187 clinical trials exploring Monitored Anesthetic Care (<a href="https://www.withpower.com/clinical-trials/mac">MAC</a>)/Local, with 42 of them being in the Phase 3 stage. While most research is conducted out of Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a>, 1319 other locations throughout the country have joined in on this investigation.

Q: What is the most frequent purpose of Monitored Anesthetic Care (MAC)/Local?

Monitored Anesthetic Care (<a href="https://www.withpower.com/clinical-trials/mac">MAC</a>)/Local is a practical way of managing cervical syndrome, minor burns, and transplantation.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up basline through year 2

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am between 40 and 95 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Oswestry Disability Index (ODI) score

Change in patient reported pain

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 / 2Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,398 Previous Clinical Trials

17,342,275 Total Patients Enrolled

Todd Alamin, MDPrincipal InvestigatorStanford University

Media Library

Lidocaine Hydrochloride, Injectable (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04992572 — Phase < 1

Lumbar Spinal Stenosis Research Study Groups: Monitored Anesthetic Care (MAC)/Local, General anesthesia

Lumbar Spinal Stenosis Clinical Trial 2023: Lidocaine Hydrochloride, Injectable Highlights & Side Effects. Trial Name: NCT04992572 — Phase < 1

Lidocaine Hydrochloride, Injectable (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04992572 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to join this experiment?

"The trial is seeking out 100 individuals with spine stenosis between 40-95 years of age. Specifically, patients will need to have lumbar decompression surgery over 1-3 segments."

Answered by AI

How many volunteers are taking part in this medical experiment?

"Affirmative. As highlighted on clinicaltrials.gov, this medical trial commenced recruiting participants in December 2021 and is still ongoing; the last update to the listing was made in May 2022. The recruitment goal of 100 patients needs to be met across 3 locations."

Answered by AI

Does the protocol for this investigation include individuals who are of advanced age?

"This trial has set the age requirement for participation between 40 and 95 years old. For those who are below 18 or above 65, there are 23 studies and 231 studies respectively open to them as an alternative."

Answered by AI

Are there still opportunities to enroll in the research project?

"Clinicaltrials.gov verifies that this investigation is currently recruiting subjects, with the original post dated December 1st 2021 and the most recent update being May 5th 2022."

Answered by AI

Could you provide a comprehensive overview of the research conducted previously concerning Monitored Anesthetic Care/Local?

"Presently, there are 187 clinical trials exploring Monitored Anesthetic Care (MAC)/Local, with 42 of them being in the Phase 3 stage. While most research is conducted out of Duarte, California, 1319 other locations throughout the country have joined in on this investigation."

Answered by AI