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Recruiting NCT04992572

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Early Phase I Interventional Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol Injection, Lidocaine Hydrochloride, Injectable.
Who it may be relevant to
Registry conditions: Lumbar Spinal Stenosis. Basic parameters: 40 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions

Overview

Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

Detailed description

100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC.

Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group.

Group 1: 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.

Group 2: 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

Interventions

  • Drug Propofol Injection
    25mg Propofol administered by injection
  • Drug Lidocaine Hydrochloride, Injectable
    Licocaine administered locally via injection.

Primary outcome measures

  • Change in Oswestry Disability Index (ODI) score [Time frame: Basline through year 2]
  • Change in patient reported pain [Time frame: Basline through year 2]

Eligibility criteria

Inclusion criteria

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

  • Ages 40-95
  • Appropriate for general anesthesia

Exclusion criteria

  • Planned significant nerve root retraction
  • Previous fusion operation
  • Unable to comply with follow up
  • Patients with daily morphine equivalents or more 100mg
  • Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.
  • Patients with allergies to eggs, egg products, soybeans or soy products.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Outpatient Surgery Center/Stanford Spine Clinic — Redwood City
  • Stanford Outpatient surgery center — Redwood City

Identifiers

NCT: NCT04992572 · 61453

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗