Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

NCT04992572 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 61453
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Change in Oswestry Disability Index (ODI) score

  Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.

  Basline through year 2

• Change in patient reported pain

  Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.

  Basline through year 2

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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.

Drug: Propofol Injection

Monitored Anesthetic Care (MAC)/Local

ACTIVE COMPARATOR

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.

Drug: Lidocaine Hydrochloride, Injectable

Interventions

Propofol Injection DRUG

25mg Propofol administered by injection

General anesthesia

Lidocaine Hydrochloride, Injectable DRUG

Licocaine administered locally via injection.

Monitored Anesthetic Care (MAC)/Local

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lumbar stenosis to be decompressed over 1-3 segments
• Ages 40-95
• Appropriate for general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Outpatient Surgery Center/Stanford Spine Clinic

Redwood City, California, 94063, United States

RECRUITING

Stanford Outpatient surgery center

Redwood City, California, 94608, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Propofol; Lidocaine; Injections

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Todd Alamin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Miller, MAS

CONTACT

650-725-7984; sarahmi@stanford.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 5, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)