Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Last updated: April 8, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

1

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

Propofol Injection

Lidocaine Hydrochloride, Injectable

Clinical Study ID

NCT04992572
61453
  • Ages 40-95
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Ages 40-95

  • Appropriate for general anesthesia

Exclusion

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 InjectableEmulsion components.

  • Patients with allergies to eggs, egg products, soybeans or soy products.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Propofol Injection
Phase: 1
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2028

Study 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

Connect with a study center

  • Outpatient Surgery Center/Stanford Spine Clinic

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Stanford Outpatient surgery center

    Redwood City, California 94608
    United States

    Active - Recruiting

  • Susmita Chatterjee

    Union City, California 94587
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.