Recruiting
Early Phase 1

Local & MAC Anesthesia

Sponsor:

Stanford University

Code:

NCT04992572

Conditions

Lumbar Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Propofol Injection

Lidocaine Hydrochloride, Injectable

Study Details

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.

Conditions

Lumbar Spinal Stenosis

Study ID

NCT04992572

Start date

Dec 1, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: General anesthesia

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.

active comparator: Monitored Anesthetic Care (MAC)/Local

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.

Interventions

Propofol Injection

25mg Propofol administered by injection

Lidocaine Hydrochloride, Injectable

Licocaine administered locally via injection.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah Miller, MAS

650-725-7984sarahmi@stanford.edu

Locations

Outpatient Surgery Center/Stanford Spine Clinic

Recruiting

Redwood City, California, United States, 94063

Contacts

Sarah Miller, MS

650-725-7984Sarahmi@stanford.edu

Stanford Outpatient surgery center

Recruiting

Redwood City, California, United States, 94608

Contacts

Susmita Chatterjee, MS/CCRP

6504979271susmitac@stanford.edu

Agnes Ith, MD

6504979271mith@stanford.edu

Principal Investigator:

Todd F Alamin, MD

More Information

Sponsor

Stanford University

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-20.