Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04992572

Enrollment

100

Registered

2021-08-05

Start date

2021-12-01

Completion date

2028-12-31

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Brief 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.

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

DRUGPropofol Injection

25mg Propofol administered by injection

DRUGLidocaine Hydrochloride, Injectable

Licocaine administered locally via injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 95 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Oswestry Disability Index (ODI) score	Basline through year 2	Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Change in patient reported pain	Basline through year 2	Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.

Countries

United States

Contacts

CONTACTSarah Miller, MAS

sarahmi@stanford.edu650-725-7984

PRINCIPAL_INVESTIGATORTodd Alamin, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026